Study of XELOX chemotherapy with or without dostarlimab after chemoradiation in patients with locally advanced rectal cancer

2 1 1 1

What is this study about?

This study focuses on patients with Locally Advanced Rectal Cancer (LARC) who have specific genetic characteristics described as pMMR/MSS or MSI-Low. The study compares two different treatment approaches after patients have completed standard chemoradiation therapy. Both treatment groups will receive XELOX, which is a combination of chemotherapy medications, but one group will also receive an additional medication called dostarlimab (also known as JEMPERLI).

The purpose of this research is to determine how well patients respond to treatment by examining whether there are any remaining cancer cells after the therapy is completed. Dostarlimab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The medication belongs to a group of drugs that help the body’s immune system fight cancer cells.

During the study, patients will receive treatment for up to 60 months. The treatment includes regular medical check-ups to monitor the patient’s health and response to therapy. Doctors will use various imaging techniques to check how well the treatment is working and to ensure the safety of the participants. The effectiveness of the treatment will be evaluated both through physical examinations and imaging tests.

1 Initial treatment phase

You will receive standard chemoradiation therapy as the first phase of treatment

After completing chemoradiation, you will be randomly assigned to one of two treatment groups

2 Consolidation treatment – Group assignment

Group A: You will receive XELOX plus dostarlimab treatment

Group B: You will receive XELOX alone treatment

The treatment you receive will be determined randomly

3 Response evaluation at 12 months

Your response to treatment will be evaluated 12 months after completing consolidation therapy

The evaluation includes digital and endoscopic examination of the rectum

An MRI scan will be performed to check for any remaining disease

4 Long-term monitoring

Your condition will be monitored at 24 and 36 months

Regular examinations will continue to check for any signs of disease

Quality of life assessments will be conducted using questionnaires

Blood samples will be collected to monitor treatment effectiveness

5 Safety monitoring

Throughout the study, you will be monitored for any side effects

Regular laboratory tests will be performed to ensure your safety

Any adverse events will be recorded and evaluated

Who Can Join the Study?

  • Must have confirmed rectal cancer (adenocarcinoma) located less than 16 cm from the anal opening
  • Must be at least 18 years old
  • Must provide written informed consent to participate
  • Must have cancer that has not spread beyond local lymph nodes (specific staging criteria apply)
  • Must have a specific type of tumor known as pMMR/MSS or MSI-Low (relates to how the tumor cells repair DNA damage)
  • Must be able to perform daily activities independently or with minimal assistance (ECOG Performance Status 0-1)
  • Must not have received any previous chemotherapy or radiation therapy
  • Must not have received any previous immunotherapy treatments (except cancer vaccines)
  • Must have adequate blood test results, including:
    • White blood cells above 1,500/mL
    • Platelets above 100,000/mL
    • Hemoglobin above 9.0 g/dL
    • Liver and kidney function within specified limits
  • Must have acceptable blood clotting test results. Patients taking blood thinners (warfarin) must have stable dosing
  • For women who can become pregnant:
    • Must not be pregnant or breastfeeding
    • Must use highly effective birth control
    • Must have a negative pregnancy test before starting the study
    • Must agree not to donate eggs during the study and for 120 days after

Who Cannot Join the Study?

  • Known hypersensitivity (severe allergic reactions) to any of the study medications
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with immune checkpoint inhibitors
  • Active autoimmune disease (condition where immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled or significant heart disease
  • Active infection requiring treatment, including hepatitis B, hepatitis C, or HIV
  • Other malignancies (cancers) within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Pregnant or breastfeeding women
  • Immunodeficiency (weakened immune system) or using immunosuppressive medications
  • Psychiatric or substance abuse disorders that could interfere with study participation
  • Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study
  • Unable to understand or provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
ARNAS Garibaldi Di Catania Catania Italy
Fondazione Poliambulanza Brescia Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Aepuyoc Ofjhuerxner Unvekurxdbdlw Pnfkf Parma Italy
Sfvc Aovwou Hoilfrmv La Spezia Italy
Iuqvraij Rcaolzgur Pql Lr Spayfp Dys Tbmtsu Dtzi Ayjkluw Iaht Swajga Meldola Italy
Amnhvgp Ofyanhsanfp Umhhwuzvmnlox Cswrhnpzeiba Dgtqw Sysdoe E Dwvfy Shyuwfg Dw Tjgxtq Turin Italy
Aaqlldh Ugv Ikhbw Ds Rjyyjf Exqaby Reggio Emilia Italy
Afurjjv Ulxcm Sdcsgjhfh Lzqdhr Df Bykblmx Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
01.10.2025

Trial locations

Investigated drugs:

Dostarlimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing your body’s natural defenses to better recognize and attack the cancer.

XELOX is a combination chemotherapy treatment that consists of two medications: capecitabine (taken as pills) and oxaliplatin (given through an IV). This combination works together to kill cancer cells and prevent them from growing and spreading.

Note: The trial compares these treatments in patients with locally advanced rectal cancer, using them after standard chemoradiation therapy. One group receives both XELOX and dostarlimab, while the other group receives only XELOX.

Investigated diseases:

Locally Advanced Rectal Cancer (LARC) – A form of rectal cancer where the tumor has grown through the wall of the rectum and may have spread to nearby tissues or lymph nodes, but has not spread to distant parts of the body. The disease develops in the last part of the large intestine, specifically in the rectum. It typically progresses from early-stage cancer confined to the rectum wall to a more advanced state where it extends beyond the rectal wall. This condition can affect the normal functioning of the bowel and may cause changes in bowel habits. The cancer can be characterized by different molecular features, including MMR (mismatch repair) and MSI (microsatellite instability) status, which influence its biological behavior.

Trial ID:
2024-519798-20-00
Protocol code:
GOIRC-02-2024
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Testing a Drug Combination with Fluorouracil, Irinotecan, Oxaliplatin, and Folinic Acid Plus Radiation Therapy for Patients with Advanced Rectal Cancer

    Recruiting

    3 1 1 1
    The Netherlands
  • Study on the Safety and Dosage of Ferumoxtran-10 for Examining Lymph Nodes in Rectal Cancer Patients Using NanoEcho Imaging Device

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden