RecruitingPhase 3NCT06086457

PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer

PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer: A Randomized Multicenter Phase III Trial

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

436 participants

Start Date

Feb 4, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Neoplasms

Summary

The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating advanced esophageal squamous cell cancer that has spread to a limited number of other organs: immunotherapy plus chemotherapy alone, versus immunotherapy plus chemotherapy combined with radiation therapy to the primary tumor. Researchers want to see if adding radiation improves outcomes. **You may be eligible if...** - You are 18 or older - You have advanced (stage IVb) squamous cell esophageal cancer confirmed by biopsy - Your cancer has spread to no more than 2 other organs (lymph nodes not counted separately) - You are in good physical condition (ECOG 0-1, or assessed as fit if age 65+) - You have not previously received chest radiation - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You have previously received thoracic (chest) radiation - You have another active cancer - You have severe heart, liver, or kidney disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation

IMRT/VMAT technique. Patients receive radiotherapy once daily, 5 days a week for an average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 50Gy in 25 fractions to planning gross tumor volume (PGTV) with involved site included.

DRUGTP or PF regimen depended on investigator's choice.

A maximum of six cycles was recommended for chemotherapy. Chemotherapy Regimen 1(TP regimen A): Nab-paclitaxel(Albumin-bound paclitaxel) 110-130mg/ m2，d1，d8; Cisplatin 60-75mg/ m2，d1；Q3W； Chemotherapy Regimen 2 (TP regimen B): Paclitaxel 150-175 mg/m2, d1; Cisplatin 60-75mg/ m2，d1；Q3W； PD-1 inhibitor 200mg, d1, Q3W Chemotherapy Regimen 3 (PF regimen): Capecitabine 800mg/m2, bid, d1-14; Cisplatin 25-30mg/m2, d1,d2, Q3W.

BIOLOGICALPD-1 inhibitor

Camrelizumab (200mg, d1, Q3W) was continued until disease progression, unacceptable toxicity, death, physician or patient decision to withdraw, non-compliance, or discontinuation for administrative reasons (up to 35 cycles).