Clinical Trials Logo
  1. Home
  2. Cholangiocarcinoma, Intrahepatic
  3. NCT04361331

Two-cohort Study of Toripalimab(PD1)+Lenvatnib, or Gemox+Lenvatinib in Advanced Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma, Intrahepatic Clinical Trial

Official title:
A Randomized, Open, Two-cohort Phase 2 Study of Toripalimab(PD1) Combined With Lenvatnib, or Gemox Chemotherapy Combined With Lenvatinib as First-line Therapy in Patients With Advanced or Unresectable Intrahepatic Cholangiocarcinoma

Clinical Trial Summary

We aim to explore the effects and safety of the two cohorts of toripalimab combined with lenvatinib or gemox combined with lenvatinib as first-line therapy in advanced or unresectable intrahepatic cholangiocarcinoma

Clinical Trial Description

For advanced intrahepatic cholangiocarcinoma (ICC) that cannot be surgically removed or accompanied by metastasis, the NCCN guidelines (NCCN guidelines hepatobiliary cancer, 2019) recommend that the current treatment options are limited, mainly recommending gemcitabine combined with platinum-based antitumor drugs (cisplatin, oxaliplatin, etc.) chemotherapy as first-line treatment. Adding targeted drugs can enhance the anti-tumor effect. For those with microsatellite instability, it is recommended to add anti-PD1(programmed cell death protein 1) antibody. Gemox chemotherapy (oxaliplatin + gemcitabine) has been used in the treatment of advanced intrahepatic cholangiocarcinoma, but the efficacy is still not satisfactory. Lenvatinib is a small-molecule multi-kinase inhibitor that is currently approved for first-line treatment of advanced hepatocellular carcinoma. In recent years, the anti-PD1 antibody has shown efficacy in the treatment of primary liver cancer. Lenvatinib combined with anti-PD1 antibody or chemotherapy may have a better effect than single use for advanced ICC. At present, lenvatinib combined with anti-PD1 antibody or lenvatinib combined with Gemox in the first-line treatment of advanced ICC has not been reported. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04361331
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 6, 2020
Completion date December 6, 2021
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
Recruiting NCT04634058 - PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment Phase 2
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
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
Recruiting NCT06381648 - Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
Available NCT03414489 - Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)