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

PHASE3RecruitingINTERVENTIONAL
Enrollment

436

Participants

Timeline

Start Date

February 4, 2024

Primary Completion Date

June 28, 2026

Study Completion Date

August 28, 2029

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).

Trial Locations (1)

100021

RECRUITING

Cancer hospital, CAMS, Beijing

All Listed Sponsors
collaborator

Peking University Cancer Hospital & Institute

OTHER

collaborator

Beijing Cancer Prevention & Treatment Society

OTHER

collaborator

Hebei Medical University Fourth Hospital

OTHER

collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

collaborator

Anyang Tumor Hospital

OTHER

collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Tengzhou Central People's Hospital

OTHER_GOV

collaborator

The First Affiliated Hospital of Xiamen University

OTHER

collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

collaborator

Changzhou Cancer Hospital of Soochow University

OTHER

collaborator

Henan Cancer Hospital

OTHER_GOV

lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER