Clinical Trials Logo
  1. Home
  2. Cholangiocarcinoma, Intrahepatic
  3. NCT04634058

PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment

Cholangiocarcinoma, Intrahepatic Clinical Trial

Official title:
PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment: a Single-arm, Phase II Clinical Study

Clinical Trial Summary

The study aims to evaluate the efficacy and safety of PD-L1 antibody combined with the CTLA-4 antibody in patients with advanced ICC who progressed after standard treatment.

Clinical Trial Description

The prognosis of unresectable and metastatic intrahepatic biliary tract cancer (ICC) is extremely poor. The median overall survival of first-line gemcitabine and cisplatin for advanced biliary tumors (including ICC) is only 11.7 months. Currently, there is no standard second-line or third-line treatment for advanced ICC, and there is an urgent need to develop new treatment methods to improve patient survival. Chronic inflammation caused by viral infections and bile duct stones is the most common potential risk factor for ICC. The abnormal immune system plays a key role in the occurrence and development of ICC. The immune checkpoint molecules PD-L1 and CTLA-4 are overexpressed in ICC, and they are obviously heterogeneous, so immunotherapy has potential value. Immune checkpoint inhibitors against PD-1/PD-L1 show a good objective remission rate in advanced biliary tumors (including ICC). CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors show significant clinical enhancement Role, CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have been clinically studied in a number of solid tumors. In this phase II clinical study, we will evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with CTLA-4 monoclonal antibody in patients with advanced ICC who progressed after standard treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04634058
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact shi Guo-ming, MD
Phone +8613916969578
Email shi.guoming@zs-hospital.sh.cn
Status Recruiting
Phase Phase 2
Start date November 1, 2020
Completion date September 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04077983 - Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT04527679 - Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Terminated NCT03267940 - Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma Phase 1
Active, not recruiting NCT03951597 - Combined Therapy Using Oxaliplatin and Gemcitabine Chemotherapy, Lenvatinib and PD1 Antibody (JS001) for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT03377179 - A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma Phase 2
Active, not recruiting NCT04361331 - Two-cohort Study of Toripalimab(PD1)+Lenvatnib, or Gemox+Lenvatinib in Advanced Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT04072250 - Surgery for Recurrent Intrahepatic Cholangiocarcinoma
Recruiting NCT05210322 - Percutaneous Cholangiopancreatoscopy Registry
Recruiting NCT04782804 - Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence Phase 1/Phase 2
Recruiting NCT04264260 - Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment Phase 2
Recruiting NCT06140134 - Liver Transplantation in Intrahepatic Cholangiocarcinoma
Enrolling by invitation NCT04195503 - Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma N/A
Recruiting NCT04506281 - PD1 Antibody (Toripalimab), GEMOX and Lenvatinib Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors Phase 2
Recruiting NCT05124002 - Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma Phase 4
Terminated NCT03316222 - Study of GNS561 in Patients With Liver Cancer Phase 1/Phase 2
Completed NCT03405909 - Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study
Available NCT03414489 - Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)