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Adenocarcinoma of colon – Trials in Disease

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Ongoing Clinical Trials for Adenocarcinoma of Colon

There are currently 11 clinical trials underway for adenocarcinoma of colon, also known as colon cancer. These studies are testing new treatment approaches including immunotherapy drugs, chemotherapy combinations, and targeted therapies across multiple countries in Europe. The trials involve patients at different stages of the disease, from early resectable cancer to advanced metastatic disease, offering hope for improved treatment outcomes.

Clinical trial locations

Study of Dostarlimab and Drug Combination for Patients with Untreated Resectable Colon Cancer

This study focuses on patients with untreated resectable colon cancer that has specific genetic characteristics called deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H). The trial compares the effectiveness of dostarlimab with standard chemotherapy treatments.

Main inclusion criteria: Patients must be at least 18 years old with untreated colon adenocarcinoma that can be surgically removed, classified as T4N0 or Stage III. The tumor must demonstrate dMMR or MSI-H characteristics. Patients must have adequate organ function and an ECOG performance status of 0 or 1, meaning they are fully active or have only minor restrictions. A tumor tissue sample from the time of diagnosis is required.

Main exclusion criteria: Patients who have already received treatment for their cancer, those with cancer that cannot be surgically removed, or those with other serious health conditions that might interfere with the study cannot participate. Pregnant or breastfeeding women are also excluded, as are patients with allergies to the study medications or certain immune system disorders.

Study focus: The main goal is to evaluate whether dostarlimab, given before and after surgery, can improve outcomes compared to standard chemotherapy regimens that may include fluorouracil, capecitabine, folinic acid, and oxaliplatin. The study will last up to 12 months with regular monitoring for side effects and treatment response.

Investigational drug: Dostarlimab is an immune checkpoint inhibitor administered intravenously. It works by blocking a protein that helps cancer cells evade the immune system, allowing the body to better attack cancer cells.

Study on FOLFOX Chemotherapy for Treating Advanced Colon Cancer in Patients Aged 70 and Older

This trial examines whether elderly patients (70 years and older) with locally advanced colon cancer benefit from receiving chemotherapy before surgery, compared to going directly to surgery.

Main inclusion criteria: Patients must be 70 years or older with biopsy-confirmed colon adenocarcinoma at radiological stage T3/T4 and N0/N1/N2 with no distant spread (M0). They must be eligible for curative surgery with no signs of bowel obstruction. The tumor must be pMMR/MSS (proficient mismatch repair/microsatellite stable), and patients must have adequate kidney and liver function. A specialist must determine they are fit to receive 6 weeks of FOLFOX chemotherapy and surgery.

Main exclusion criteria: Patients with cancers other than colon carcinoma, those who have had previous treatment, pregnant or breastfeeding women, and those currently participating in another clinical trial cannot join.

Study focus: The trial evaluates whether receiving three courses of FOLFOX chemotherapy (folinic acid, oxaliplatin, and fluorouracil) over 6 weeks before surgery improves disease-free survival and quality of life compared to surgery alone. The study will monitor patients for up to 3 years after surgery.

Investigational drugs: FOLFOX is a combination of three chemotherapy drugs that work together to stop cancer cells from growing and dividing. It is given intravenously before surgery to potentially shrink the tumor.

Study on Pre-Surgery Immunotherapy with Relatlimab, Anti-IL-8 mAb, and Ipilimumab for Early-Stage Colon Cancer Patients

This study investigates the use of several immunotherapy medications given before surgery in patients with early-stage, non-rectal colon cancer.

Main inclusion criteria: Patients must be at least 18 years old with non-metastatic adenocarcinoma of the colon or rectosigmoid (considered non-rectal). The cancer must be at stage greater than cT3 and/or N+ (meaning it has grown beyond certain layers of the colon wall or spread to lymph nodes). Patients must have adequate blood counts, liver function, and kidney function (creatinine clearance above 40 ml/min). A colonoscopy with study-specific biopsies is required. The WHO performance status must be 0 or 1.

Main exclusion criteria: The trial does not list specific exclusion criteria beyond general requirements, but patients who cannot undergo the required colonoscopy or who have significantly impaired organ function would not be eligible.

Study focus: The trial assesses the safety and feasibility of giving immunotherapy combinations before surgery. The main goal is to determine if patients can proceed to surgery within the planned 6 to 8 weeks and to measure how well the cancer responds to treatment before removal.

Investigational drugs: The study uses several immune checkpoint inhibitors (Relatlimab, anti-IL-8 mAb, Ipilimumab, and Nivolumab) given intravenously, along with Celecoxib taken orally. These medications work by helping the immune system recognize and attack cancer cells.

Study on Preoperative Chemoradiotherapy with Capecitabine and Temozolomide for Patients with Locally Advanced Rectal Cancer

This trial studies the combination of chemoradiotherapy using capecitabine and temozolomide in patients with a specific type of rectal cancer that has particular genetic characteristics.

Main inclusion criteria: Patients must be at least 18 years old with confirmed rectal adenocarcinoma that is MGMT silenced and microsatellite stable. The cancer must be locally advanced but surgically removable, located less than 15 cm from the anal verge, and staged as cT3N0 or cT1-3N1 with fewer than four suspicious lymph nodes on MRI. Patients must have adequate blood counts, liver function, kidney function, and an ECOG performance status of 0-1. Life expectancy must be at least 5 years aside from the cancer diagnosis.

Main exclusion criteria: Patients with other types of cancer, those without MGMT silencing, those with microsatellite instability, pregnant or breastfeeding women, and vulnerable populations cannot participate.

Study focus: The trial investigates whether adding temozolomide to the standard chemoradiation treatment with capecitabine can improve how well the cancer responds before surgery. The goal is to increase the rate of major pathological response and complete response, potentially allowing for more successful surgical outcomes.

Investigational drugs: Capecitabine and temozolomide are both chemotherapy medications taken orally. Capecitabine is part of standard treatment, while temozolomide is being added to see if it enhances the treatment’s effectiveness by damaging cancer cell DNA.

Study on Temozolomide and Irinotecan for Patients with Stage II/III Colorectal Cancer and Positive ctDNA After Chemotherapy

This study, called ERASE-TMZ, focuses on patients with stage II or III colorectal cancer who still have detectable cancer DNA in their blood after completing standard chemotherapy.

Main inclusion criteria: Patients must be at least 18 years old with stage III or T4N0 stage II colon cancer or locally-advanced resectable rectal cancer. They must have completed radical surgery and at least 3 months of oxaliplatin-based chemotherapy. The tumor must be MGMT silenced, microsatellite stable (MSS), and patients must have positive circulating tumor DNA (ctDNA) detected in blood samples 2-6 weeks after finishing standard chemotherapy. Adequate organ function and ECOG performance status of 0-1 are required.

Main exclusion criteria: Patients who haven’t completed oxaliplatin-based chemotherapy, those without positive ctDNA after treatment, and those with cancer that is not microsatellite stable or MGMT silenced cannot participate.

Study focus: The trial tests whether the combination of temozolomide and irinotecan (TEMIRI regimen) can eliminate detectable cancer DNA from the blood and keep patients disease-free for two years. This consolidation therapy is given after standard treatment in patients at high risk for cancer recurrence.

Investigational drugs: Temozolomide is taken orally and works by damaging cancer cell DNA. Irinotecan is given by injection and prevents cancer cells from dividing. Together, these medications aim to eliminate remaining cancer cells detected through blood tests.

Study Comparing FOLFIRI with Cetuximab or Bevacizumab for First-Line Treatment in Patients with Metastatic Colorectal Cancer and Specific Genetic Profiles

This trial compares two treatment combinations for patients with metastatic colorectal cancer that has specific genetic characteristics.

Main inclusion criteria: Patients must be over 18 years old with confirmed colorectal adenocarcinoma that is RAS/BRAF wild type in tissue but shows RAS/BRAF mutations in liquid biopsy (blood test). The cancer must be metastatic and unresectable, with no prior chemotherapy for metastatic disease. Patients must be suitable for first-line chemotherapy with at least one measurable tumor site according to RECIST 1.1 guidelines. ECOG performance status must be 2 or less, with adequate bone marrow, liver, and kidney function. Life expectancy must exceed 3 months.

Main exclusion criteria: Patients who have received prior treatment for metastatic disease or are not candidates for FOLFIRI plus cetuximab or bevacizumab cannot participate.

Study focus: The study determines which combination—FOLFIRI with cetuximab or FOLFIRI with bevacizumab—is more effective in delaying cancer progression. FOLFIRI is a chemotherapy regimen including folinic acid, fluorouracil, and irinotecan. The trial will assess progression-free survival, overall survival, and treatment safety.

Investigational drugs: FOLFIRI is a standard chemotherapy combination. Cetuximab is a targeted therapy that blocks a protein on cancer cell surfaces, while bevacizumab blocks a different protein that helps tumors grow blood vessels. Both are given intravenously alongside chemotherapy.

Study on Atezolizumab with FOLFOX for Stage III Colon Cancer with Deficient DNA Mismatch Repair

This study investigates whether adding immunotherapy to standard chemotherapy improves outcomes in stage III colon cancer patients with deficient DNA mismatch repair.

Main inclusion criteria: Patients must be at least 18 years old with confirmed stage III colon adenocarcinoma showing deficient DNA mismatch repair (dMMR). The tumor must be completely removed through surgery (R0 resection) and located entirely in the colon, not the rectum. ECOG performance status must be 2 or less. Adequate blood counts are required: platelets at least 100,000 per cubic millimeter, absolute neutrophil count at least 1,500 per cubic millimeter. Creatinine levels must not exceed 1.5 times normal, or creatinine clearance must be at least 45 mL/min. Liver function tests (bilirubin, AST/ALT) must be within specified limits. Tumor tissue must be available for testing.

Main exclusion criteria: Patients with cancer types other than stage III colon adenocarcinoma with dMMR, those outside the specified age range, vulnerable populations, and those with conditions that could interfere with treatment safety are excluded.

Study focus: The trial evaluates whether combining atezolizumab (an immunotherapy) with FOLFOX chemotherapy (folinic acid, fluorouracil, and oxaliplatin) improves disease-free survival compared to FOLFOX alone. The treatment is given after surgery to prevent cancer recurrence.

Investigational drugs: Atezolizumab is an immune checkpoint inhibitor given intravenously that helps the immune system recognize and attack cancer cells. FOLFOX is a standard chemotherapy regimen that interferes with cancer cell DNA to prevent their growth and division.

Study on Holmium-166 TARE and Maintenance Therapy with Capecitabine, Bevacizumab, and Drug Combination for Patients with Unresectable Liver-Colorectal Cancer

This trial studies a specialized liver treatment followed by maintenance therapy in patients whose colorectal cancer has spread to the liver but cannot be surgically removed.

Main inclusion criteria: Patients must be at least 18 years old with confirmed colorectal adenocarcinoma and liver-only disease affecting less than 50% of the liver volume. They must have received 6-12 cycles of first-line chemotherapy (FOLFOX, FOLFIRI, XELOX, or FOLFOXIRI with bevacizumab or anti-EGFR drugs) and achieved partial response or stable disease per RECIST 1.1 criteria, with cancer remaining unresectable. Life expectancy must be at least 12 weeks. Adequate blood counts, liver function, and kidney function (creatinine clearance above 50 mL/min) are required. For specific cohorts, tumors must be either RAS/BRAF wild-type and left-sided (Cohort A) or RAS mutated and/or right-sided (Cohort B).

Main exclusion criteria: Patients with cancer spread beyond the liver, those with prior other cancers (with certain exceptions), recent heart problems, uncontrolled high blood pressure, severe liver or kidney disease unrelated to cancer, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.

Study focus: The study assesses the effectiveness of Holmium-166 TARE (a targeted radiation treatment delivered directly to liver tumors) followed by maintenance therapy with fluoropyrimidine plus either anti-EGFR or anti-VEGF medications. The goal is to prevent cancer progression over several months.

Investigational drugs: Holmium-166 TARE uses radioactive beads delivered to liver tumors to kill cancer cells. Maintenance therapy includes fluoropyrimidine chemotherapy combined with either anti-EGFR therapy (blocking cancer cell growth signals) or anti-VEGF therapy (cutting off blood supply to tumors).

Study of Durvalumab and Regorafenib for Patients with Stage IV Colorectal Cancer with No Evidence of Disease

This study examines whether treatment with durvalumab and regorafenib can help prevent cancer recurrence in stage IV colorectal cancer patients who currently show no evidence of disease.

Main inclusion criteria: Patients must be at least 18 years old with confirmed colorectal adenocarcinoma and must be in a state of no evidence of disease (NED) after completing treatments for stage IV disease. The NED state must be verified by CT, PET, or MRI scans. Randomization must occur within 10 weeks of achieving NED status. For patients who received additional therapy after local treatment or achieved complete response with systemic therapies, randomization must occur within 4 weeks of the last chemotherapy cycle.

Main exclusion criteria: Patients without stage IV colorectal cancer or those not in NED status cannot participate.

Study focus: The trial evaluates whether the combination of durvalumab (given intravenously) and regorafenib (taken orally) can extend disease-free survival compared to no additional treatment. The study will run for up to 12 months with close monitoring of participants’ health.

Investigational drugs: Durvalumab is an immunotherapy that helps the immune system attack cancer cells by blocking the PD-L1 protein. Regorafenib is a targeted therapy taken orally that interferes with proteins involved in cancer cell growth and blood vessel formation.

Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

This trial studies tisotumab vedotin alone and in combination with pembrolizumab and platinum chemotherapy in patients with advanced or metastatic solid tumors, including colorectal cancer.

Main inclusion criteria: Patients must have relapsed, locally advanced, or metastatic colorectal or pancreatic cancer, squamous non-small cell lung cancer, or squamous cell carcinoma of the head and neck that has not responded to previous treatments and cannot be treated with standard therapy. The disease must be measurable according to specific guidelines. Patients must be able to provide a tumor tissue sample for testing. Both men and women can participate, and patients must be adults within certain age ranges.

Main exclusion criteria: Patients with cancers other than solid tumors, those not diagnosed with locally advanced or metastatic disease, those outside the specified age range, and those unable to follow study procedures are excluded.

Study focus: The study assesses the antitumor activity of tisotumab vedotin alone and in various combinations with pembrolizumab (an immunotherapy) and platinum agents like cisplatin or carboplatin (chemotherapy drugs). The trial monitors tumor response, duration of response, and overall survival.

Investigational drugs: Tisotumab vedotin is an antibody-drug conjugate that delivers a cytotoxic agent directly to cancer cells. Pembrolizumab helps the immune system fight cancer. Platinum agents are chemotherapy drugs that damage cancer cell DNA. All are administered intravenously.

Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy

This trial investigates whether atezolizumab can improve disease-free survival in patients with high-risk stage II or stage III colorectal cancer who cannot receive standard oxaliplatin-based chemotherapy.

Main inclusion criteria: Patients must be 18 years or older with confirmed colon or rectal adenocarcinoma that is MSI-high (MSI-H) or MMR-deficient (dMMR). The cancer must be high-risk stage II or stage III and completely removed through successful surgery (R0 or R1 resection). Patients must be unable to receive or choose not to receive oxaliplatin-based chemotherapy. ECOG performance status must be 0 to 2. Adequate blood counts, liver function, and kidney function are required, with INR and PTT less than 1.5 times normal within 7 days before joining.

Main exclusion criteria: Patients with different cancer types, those who have received oxaliplatin-based chemotherapy, those whose tumors haven’t been completely removed, pregnant or breastfeeding women, and those with various serious health conditions or participating in another trial are excluded.

Study focus: The study evaluates whether atezolizumab, given as adjuvant treatment after surgery, can improve the 3-year disease-free survival rate compared to placebo in patients with MSI-H or dMMR colorectal cancer who cannot use standard chemotherapy. Treatment continues for up to 12 months.

Investigational drug: Atezolizumab is an immune checkpoint inhibitor administered intravenously that blocks the PD-L1 protein, enabling the immune system to recognize and destroy cancer cells more effectively.

Summary

The 11 ongoing clinical trials for adenocarcinoma of colon represent diverse approaches to treating this disease at various stages. A notable concentration of trials is occurring in Italy (7 trials) and Germany (4 trials), with France and Spain also hosting multiple studies. The trials span from early-stage resectable disease to advanced metastatic cancer.

Several trials focus on immunotherapy approaches, particularly for tumors with specific genetic characteristics such as MSI-high or dMMR status. Dostarlimab, atezolizumab, and durvalumab are among the immune checkpoint inhibitors being studied in multiple trials, either alone or in combination with standard chemotherapy regimens like FOLFOX and FOLFIRI.

A significant number of trials target patients with particular genetic profiles, including MGMT silencing, RAS/BRAF mutations, and microsatellite stability. This reflects the growing trend toward personalized medicine in cancer treatment. Elderly patients are specifically addressed in one French trial examining FOLFOX chemotherapy in patients aged 70 and older.

The trials employ various treatment strategies including neoadjuvant therapy (before surgery), adjuvant therapy (after surgery), and treatments for patients with no evidence of disease after initial treatment. Several studies investigate novel combinations of existing drugs or add new agents to standard regimens. Specialized approaches such as Holmium-166 TARE for liver-limited disease demonstrate innovation in treating specific clinical scenarios.

Ongoing Clinical Trials on Adenocarcinoma of colon

  • Study on FOLFOX Chemotherapy for Treating Advanced Colon Cancer in Patients Aged 70 and Older

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Atezolizumab with FOLFOX for Stage III Colon Cancer with Deficient DNA Mismatch Repair

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Holmium-166 TARE and Maintenance Therapy with Capecitabine, Bevacizumab, and Drug Combination for Patients with Unresectable Liver-Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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