Clinical Trials Logo

Clinical Trial Summary

This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.


Clinical Trial Description

Pucotenlimab is a new humanized PD-1-specific monoclonal antibody. On September 29, 2022, the National Medical Products Administration of China approved the marketing application of Pucotenlimab Injection for the treatment of patients with microsatellite highly unstable (MSI-H)/mismatch repair function defective (dMMR) solid tumors who have failed prior first-line and above systemic therapy. There have been studies and reports on systemic chemotherapy with GEMOX regimen combined with lenvatinib and PD-1 monoclonal antibody for the treatment of intrahepatic cholangiocarcinoma. Currently, a multicenter, phase 2 study evaluating the efficacy of pucotenlimab in patients with mismatch repair-deficient (dMMR) or microsatellite instabilityhigh (MSI-H) tumors is underway. The objective response rate (ORR) is 49.0% (95% CI 38.86%-59.20%), while the median progression-free survival and overall survival have not been reached. Grade ≥3 treatment-related adverse events were observed in 18 of 100 patients. The efficacy of this antibody in patients is promising. Based on the results of these previous studies, this study intends to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (GEMOX regimen) combined with lenvatinib and pucotenlimab in the down-stage conversion treatment of patients with unresectable intrahepatic cholangiocarcinoma. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06192797
Study type Interventional
Source Tongji Hospital
Contact Ze-yang Ding
Phone +8613407156200
Email zyding@tjh.tjmu.edu.cn
Status Recruiting
Phase Phase 2
Start date June 4, 2024
Completion date June 1, 2026

See also
  Status Clinical Trial Phase
Completed NCT03043547 - Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies 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 NCT06081829 - A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation Phase 2
Completed NCT03473574 - Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients 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
Terminated NCT02166190 - RFA RCT for Pancreatic or Bile Duct Cancer N/A
Recruiting NCT03364530 - Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma Phase 2
Recruiting NCT05978609 - Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer Phase 2
Recruiting NCT05655949 - Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio Phase 2
Recruiting NCT06194695 - DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma
Recruiting NCT06192784 - Combined DEB-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT04860154 - Photodynamic Therapy for Cholangiocarcinoma N/A
Available NCT03414489 - Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)