MedTrace Logo

Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

NCT04333927 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-06-23

No results posted yet for this study

Summary

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

Conditions

  • Biliary Tract Cancer
  • Extrahepatic Cholangiocarcinoma
  • Gallbladder Cancer

Interventions

DRUG

Chemotherapy

Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).

OTHER

Observation

Patients in observation group will not receive any anti-cancer therapy.

PROCEDURE

Immunotherapy

Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.

RADIATION

Radiotherapy

45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Kuang, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333927 on ClinicalTrials.gov