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Oesophageal squamous cell carcinoma – Trials in Disease

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Ongoing Clinical Trials for Oesophageal Squamous Cell Carcinoma

There are currently 12 ongoing clinical trials exploring new treatment approaches for oesophageal squamous cell carcinoma across multiple European countries. These trials investigate various combinations of chemotherapy, radiotherapy, and immunotherapy drugs, aiming to improve treatment outcomes for patients with this challenging cancer type.

Clinical trial locations

Study Comparing Chemoradiotherapy with Fluorouracil, Cisplatin, and Carboplatin for Patients with Operable Esophageal Squamous Cell Carcinoma

This trial compares two treatment approaches for operable, locally advanced disease. Patients must have histologically confirmed squamous cell carcinoma that is technically removable by surgery, with an ECOG performance status of 0-1, adequate organ function, and be between 18 and 80 years old. Women of childbearing potential must have a negative pregnancy test and use effective birth control.

Excluded are patients with different cancer types, cancer that cannot be removed by surgery, other serious health conditions, pregnancy or breastfeeding, recent participation in other trials, allergies to study medications, recent heart attacks or serious heart problems, active infections requiring treatment, or a history of another cancer within the last five years.

The trial compares neoadjuvant chemoradiotherapy followed by surgery versus definitive chemoradiotherapy with surgery only if needed. The goal is to determine if the second approach offers comparable overall survival. Medications include fluorouracil, cisplatin, carboplatin, paclitaxel, folinic acid, and oxaliplatin, administered through intravenous infusion. Patients are monitored over several years to assess survival, quality of life, and side effects.

Study of Atezolizumab and Tiragolumab for Patients with Unresectable Esophageal Squamous Cell Carcinoma After Chemoradiotherapy

This trial is for patients with unresectable disease who have completed chemoradiotherapy. Eligibility requires histologically proven squamous cell carcinoma, completion of at least two cycles of platinum-based chemotherapy and radiation without progression, and randomization within 1 to 84 days after the last radiation dose. Patients must have Stage II-IVA cancer deemed inoperable, at least one evaluable or measurable lesion per RECIST v1.1 criteria, and be 70 years or older with a WHO performance status of 2 or less. Tumor tissue for PD-L1 testing must be available, and patients must not have active hepatitis B or untreated hepatitis C.

Exclusions include other cancer types, previous treatment with the same drugs, serious heart problems, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding, severe allergic reactions to similar drugs, autoimmune diseases, current participation in another trial, and severe liver or kidney disease.

The study tests atezolizumab, an immune checkpoint inhibitor that blocks PD-L1 to help the immune system attack cancer cells, combined with tiragolumab, an experimental drug designed to enhance atezolizumab’s effects. Some participants receive both drugs, while others receive atezolizumab with placebo or a double placebo. The study evaluates progression-free survival and overall survival, administered via intravenous infusion over up to 51 weeks.

Study of Ifinatamab Deruxtecan and Chemotherapy for Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma

This trial is for patients with unresectable locally advanced or metastatic disease who have experienced progression after platinum-based and immune checkpoint inhibitor treatments. Participants must be at least 18 years old, have confirmed diagnosis, disease progression after only one previous line of systemic therapy, an adequate tumor sample, at least one measurable lesion on CT or MRI, and an ECOG performance status of 0 or 1.

Excluded are patients with other cancer types, those who received certain non-allowed treatments, severe or uncontrolled medical conditions, pregnancy or breastfeeding, recent participation in another trial, known allergies to study drugs, and inability to comply with study procedures.

The study compares ifinatamab deruxtecan, an antibody-drug conjugate targeting cancer cells, to chemotherapy options including docetaxel, irinotecan hydrochloride, and paclitaxel. The treatment is given through intravenous infusion over up to 54 weeks. The trial aims to determine if ifinatamab deruxtecan can help patients live longer compared to standard chemotherapy, while monitoring quality of life and side effects.

Study of Ifinatamab Deruxtecan and Pembrolizumab, With or Without Chemotherapy, for Patients With Untreated Advanced Esophageal Cancer

This trial investigates treatments for patients with locally advanced unresectable or metastatic squamous cell carcinoma who have not previously received treatment. Patients must have confirmed diagnosis, measurable disease, side effects from previous treatments that are mild or returned to baseline (except hair loss and skin changes), an ECOG performance status of 0 or 1, and be within the specified adult age range.

Exclusions include other cancer types, age outside the specified range, vulnerable populations, failure to recover from previous treatments, severe or uncontrolled medical conditions, current participation in another trial, severe allergic reactions to similar treatments, pregnancy or breastfeeding, active infections requiring treatment, and history of drug or alcohol abuse.

The study explores ifinatamab deruxtecan combined with pembrolizumab, with or without chemotherapy drugs such as oxaliplatin, fluorouracil, and calcium folinate. The medications are administered through intravenous infusion. The trial evaluates safety, tolerability, optimal dosing, duration of response, progression-free survival, and overall survival rates.

Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal

This trial aims to prevent esophageal strictures following endoscopic submucosal dissection. Participants must be 18 to 85 years old, have at least one year of life expectancy, an ECOG performance status of 2 or less, histological evidence of squamous cell carcinoma or high-grade dysplasia treated with endoscopic dissection, and a mucosal defect covering at least 50% of the esophagus for squamous cell carcinoma or 75% for other conditions. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.

Exclusions include non-adults, those who have not undergone endoscopic submucosal dissection, inability to take study medication, medical conditions interfering with the study, pregnancy or breastfeeding, participation in another trial, severe allergic reactions to the medication, and inability to understand or follow study instructions.

The study tests budesonide orodispersible tablets at doses of either 2 x 1 mg or 2 x 2 mg per day versus placebo for eight weeks. The goal is to determine the percentage of patients free of strictures by the end of the study period and track the number of endoscopic dilations required.

Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

This trial includes patients with various cancer types, including esophageal squamous cell carcinoma, who have shown partial or complete response after six months of standard immunotherapy. Participants must have signed informed consent, be at least 18 years old, have confirmed diagnosis of locally advanced or metastatic cancer, be in partial or complete response after six months of immunotherapy, be eligible to continue the same treatment, and have an ECOG performance status of 0 or 1. Patients with stable brain metastases and those previously treated with immunotherapy combined with chemotherapy or specific drug combinations are allowed.

Exclusions are limited to patients who have not been diagnosed with the specified cancer types, have not shown adequate response to treatment after six months, and melanoma patients without partial response.

The study compares standard immunotherapy with reduced-dose immunotherapy administered every three months. Medications include pembrolizumab, durvalumab, avelumab, nivolumab, dostarlimab, atezolizumab, and cemiplimab, given through intravenous infusion. The trial evaluates whether the reduced dose maintains effectiveness in controlling cancer while potentially reducing side effects, monitoring progression-free survival, quality of life, and side effects over up to three years.

Study on Tislelizumab for Elderly Patients with Advanced Esophageal Squamous Cell Carcinoma Unfit for Chemotherapy

This trial is specifically for elderly patients unfit for chemotherapy. Participants must have histologically proven squamous cell carcinoma that is metastatic or locally advanced, have not received previous immunotherapy, chemotherapy, or radiotherapy in the first-line setting, be considered ineligible for platinum-based chemotherapy by an oncologist and geriatrician, have at least one evaluable or measurable lesion per RECIST v1.1, be 70 years or older, and have a WHO performance status of 2 or less. Tumor tissue for PD-L1 testing must be available, and patients must not have active hepatitis B or detectable hepatitis C.

Exclusions include other cancer types, failure to receive at least one dose of treatment, loss to follow-up, and death within six months after inclusion.

The study evaluates tislelizumab, an immune checkpoint inhibitor that blocks PD-1 to help the immune system recognize and attack cancer cells. Administered as an intravenous infusion, the trial assesses survival rates at six months, overall survival, treatment response, and quality of life, providing a treatment option for elderly patients who cannot tolerate aggressive therapies.

Study on Bintrafusp Alfa with Chemoradiation for Patients with Esophageal Squamous Cell Carcinoma

This trial tests bintrafusp alfa, a special protein designed to block PD-L1 and TGF-β pathways, combined with chemotherapy and radiation. Participants must have confirmed diagnosis of surgically irresectable squamous cell carcinoma, normal blood, kidney, and liver functions, and provide written consent. Patients must be able to attend treatment center visits, be at least 18 years old, and have an ECOG performance status of 0-2. If the tumor extends below the gastroesophageal junction, most of it must remain in the esophagus or junction area.

Exclusions include other cancer types and inability to complete the treatment plan involving bintrafusp alfa with chemoradiation. Age restrictions apply, and vulnerable populations are excluded.

Bintrafusp alfa is given as an intravenous infusion alongside chemotherapy drugs carboplatin and paclitaxel, plus radiation therapy. The treatment aims to target cancer cells while stopping them from dividing and growing. The study observes completion rates of at least two out of three planned cycles, monitoring safety, cancer response, and quality of life, including symptoms like difficulty swallowing.

Study of Durvalumab with Chemoradiation Therapy for Patients with Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma

This trial tests durvalumab alongside chemoradiation therapy for locally advanced, unresectable disease. Patients must be at least 18 years old, have histologically confirmed squamous cell carcinoma at Stage II to IVA that is unresectable or the patient refuses surgery, be suitable for definitive chemoradiation therapy, have at least one evaluable lesion per RECIST 1.1, provide tumor tissue for PD-L1 testing, have an ECOG performance status of 0 or 1, adequate organ and marrow function, and a life expectancy exceeding three months.

Exclusions include other cancer types, previous non-allowed treatments, other serious health conditions, pregnancy or breastfeeding, allergies to study medication, inability to follow study procedures, current participation in another trial, recent infection requiring antibiotics, certain heart conditions, and recent live vaccine administration.

Durvalumab blocks a specific protein that stops the immune system from attacking cancer cells, administered through intravenous infusion alongside chemotherapy drugs fluorouracil, cisplatin, and capecitabine, plus radiation therapy. Some participants receive placebo instead of durvalumab. The trial evaluates progression-free survival in patients with specific tumor characteristics, monitoring response, quality of life, and side effects.

Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

This trial studies JK08, an IL-15 antibody fusion protein targeting CTLA-4, both alone and in combination with pembrolizumab and lenvatinib. Participants must be at least 18 years old, agree to tumor biopsies before and during treatment, have confirmed unresectable locally advanced or metastatic cancer treated unsuccessfully with standard therapies, a performance status of 0 or 1, life expectancy of at least 12 weeks, measurable disease per RECIST criteria, acceptable lab test results, and provide a previous tumor sample. Women of childbearing potential must have a negative pregnancy test and use effective birth control. Men with partners who can become pregnant must use barrier birth control. Patients with treated, asymptomatic brain metastases are allowed.

Exclusions are not explicitly detailed beyond standard trial criteria.

JK08 is administered subcutaneously once weekly to determine the safest and most effective dose. Some patients also receive pembrolizumab via intravenous infusion or lenvatinib as oral capsules. The study evaluates safety, tolerability, optimal dosing, and effectiveness in treating advanced cancers, providing insights into new therapeutic options for patients with limited treatment choices.

Study of Lenvatinib, Pembrolizumab, and Chemotherapy Combination for Patients with Advanced Esophageal Cancer Previously Treated with PD-1/PD-L1 Therapy

This trial explores combination therapies for patients with advanced disease who have progressed after one prior standard treatment including a platinum agent and PD1/PD-L1 therapy. Participants must have confirmed diagnosis of metastatic or locally advanced unresectable disease, disease progression after prior treatment, a tumor sample available for analysis, and well-controlled blood pressure. Previous treatment side effects must have improved to mild levels or returned to baseline, except hormone-related side effects managed with hormone replacement or mild neuropathy.

Exclusions include other cancer types, failure to recover from previous treatments, serious heart problems, uncontrolled infections, pregnancy or breastfeeding, severe allergic reactions to similar treatments, certain autoimmune diseases, recent receipt of another investigational drug, certain brain conditions or recent stroke, severe liver or kidney problems, and inability to follow study procedures.

The study tests lenvatinib, MK-4830, MK-2870 (sacituzumab tirumotecan), and pembrolizumab in various combinations, compared to placebo. Medications are administered intravenously or orally. The trial begins with a safety lead-in phase, followed by efficacy assessment measuring objective response rate, progression-free survival, duration of response, and overall survival, aiming to determine the best combination to improve outcomes.

Due to the large number of trials, detailed descriptions are provided for the first 10 studies. Two additional trials are available in this research area but not described in full detail here.

Summary

The 12 ongoing clinical trials for oesophageal squamous cell carcinoma reflect a diverse research landscape across Europe, with particularly strong representation in France, Germany, Italy, and Spain. Several countries host multiple trials, providing patients with various treatment options depending on their specific disease stage and previous treatments.

The trials can be broadly categorized into several treatment approaches: studies comparing neoadjuvant chemoradiotherapy with definitive chemoradiotherapy, trials testing immune checkpoint inhibitors like atezolizumab, tiragolumab, durvalumab, pembrolizumab, and tislelizumab, investigations of antibody-drug conjugates such as ifinatamab deruxtecan, and combination therapies integrating immunotherapy with chemotherapy or targeted agents.

A notable trend is the focus on immunotherapy-based treatments, with multiple trials evaluating checkpoint inhibitors either as single agents or in combination with other therapies. Several studies specifically target patients who have progressed on prior treatments, addressing an important unmet need for second-line therapies. Other trials focus on elderly patients unfit for standard chemotherapy, expanding treatment options for vulnerable populations.

One unique trial investigates budesonide tablets for preventing esophageal strictures following endoscopic procedures, addressing a quality-of-life issue for patients undergoing cancer tissue removal. The research also includes studies examining dose reduction strategies for patients responding to immunotherapy, potentially improving tolerability while maintaining effectiveness.

These trials collectively represent significant efforts to improve treatment outcomes, extend survival, maintain quality of life, and reduce treatment-related side effects for patients with this challenging cancer type across various disease stages and patient populations.

Ongoing Clinical Trials on Oesophageal squamous cell carcinoma

  • Study of Ifinatamab Deruxtecan and Chemotherapy for Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Italy The Netherlands +5

  • Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Tislelizumab for Elderly Patients with Advanced Esophageal Squamous Cell Carcinoma Unfit for Chemotherapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study Comparing Chemoradiotherapy with Fluorouracil, Cisplatin, and Carboplatin for Patients with Operable Esophageal Squamous Cell Carcinoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Ireland Norway Sweden

  • Study of Durvalumab with Chemoradiation Therapy for Patients with Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Poland Spain

  • Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Spain

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