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

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.

Conditions

• Esophageal Neoplasms

Interventions

RADIATION

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 50Gy in 25 fractions to planning gross tumor volume (PGTV) with involved site included.

DRUG

TP 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.

BIOLOGICAL

PD-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).

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Beijing Cancer Prevention & Treatment Society

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Anyang Tumor Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Tengzhou Central People's Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Changzhou Cancer Hospital of Soochow University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Lin Shen, MD · Peking University Cancer Hospital & Institute

• Wen-Yang Liu, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-04

Primary Completion

2026-06-28

Completion

2029-08-28

Countries

• China

Study Locations