RecruitingPhase 2NCT06084897

Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy

Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

120 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

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 II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy. 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 tests whether adding radiotherapy (radiation treatment) to ongoing treatment can improve outcomes in patients with metastatic esophageal cancer (squamous cell type) who have already responded well to first-line immunotherapy plus chemotherapy. **You may be eligible if...** - You are 18 or older - You have squamous cell carcinoma of the esophagus at stage IVb (widely spread), or recurrent after prior curative treatment - You have responded to 2 to 4 cycles of chemotherapy combined with an immunotherapy (PD-1 inhibitor) - Your overall health is good (ECOG performance status 0 or 1) - Your blood counts and organ function are within normal limits **You may NOT be eligible if...** - You have a history of another cancer (except some skin cancers or cervical cancer in situ) - You received surgery, chemotherapy, or other cancer treatment before joining this study - You have an active infection or had a recent heart attack, stroke, or major surgery in the past 6 months - You have an allergy to chemotherapy drugs or a history of serious autoimmune disease - You are enrolled in another trial or within 4 weeks of leaving one 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

DRUGTP (Paclitaxel with cisplatin or carboplatin) or PF (Fluoropyrimidine with cisplatin or carboplatin) regimen depended on investigator's choice.

A maximum of six cycles was recommended for chemotherapy. * Fluoropyrimidine (fluorouracil or capecitabine) with carboplatin or cisplatin; * Paclitaxel (or Albumin-bound paclitaxel) with carboplatin or cisplatin.

BIOLOGICALPD-1 inhibitor

Nivolumab or Pembrolizumab or Tislelizumab or Serplulimab or Toripalimab or Sintilimab or Camrelizumab

RADIATIONConsolidation Radiation

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 49.22Gy/23f or 50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66Gy/19f or 40Gy/20f for organ metastasis patients. Radiation treatment is planned after chemotherapy completed.

RADIATIONSalvage Radiation

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 49.22Gy/23f or 50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66\~49.22Gy/19f \~23f or 40\~50Gy/20\~25f for organ metastasis patients. Radiation treatment is planned after disease progression when recommended by multidisciplinary team.


Locations(1)

Cancer hospital, CAMS

Beijing, Beijing Municipality, China

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NCT06084897