Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

Summary

A randomized controlled, multicenter, open, seamless phase II-III clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors which has extremely low postoperative recurrence-free survival. In this study, we aim to compare the prognosis in intrahepatic cholangiocarcinoma between Toripalimab combined with leventinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment (traditional group).

Conditions

• Intrahepatic Cholangiocarcinoma
• PD1 Antibody
• Lenvatinib
• Gemox Chemotherapy

Interventions

DRUG

Neoadjuvant treatment

PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• RenJi Hospital

  collaborator OTHER

• Shenzhen University General Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Eastern Hepatobiliary Surgery Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• The First Hospital of Hebei Medical University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Jia Fan, MD & PhD · Shanghai Zhongshan Hospital

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

2021-01-20

Primary Completion

2025-04-30

Completion

2026-12-31

Countries

• China

Study Locations