Cholangiocarcinoma Non-resectable Clinical Trial
Official title:
Combination of Transcatheter Arterial Chemoembolization With Drug-eluting Beads, Lenvatinib and Anti-PD(L)1 Antibody for Downstaging Intrahepatic Cholangiocarcinoma for Radical Surgical Treatment
The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of Drug-eluting Beads-transarterial chemoembolization (DEB-TACE), lenvatinib, and anti-PD-1/ PD-L1 antibody for patients with advanced intrahepatic cholangiocarcinoma who were initially unsuitable for the radical therapy, including resection, transplantation, or ablation.
The multicenter, non-random, open and prospective real-world cohort study is conducted at 4 research centers, including 3 centers (Hankou, Sino-French New District, and Optical Valley) of Tongji hospital (Wuhan, China) and one in the second affiliated hospital of Fujian Medical University (Quanzhou, China). It is estimated that 100 patients with advanced intrahepatic cholangiocarcinoma will be enrolled in these 4 research centers. And it is planned to complete the enrollment within 2 year and it is expected that all enrolled subjects will reach the observation end point in 3 years. Radiological assessments are performed every two cycles over the course of treatment, then every 3 months within the first two years following the completion of treatment and every 6 months thereafter, until PD were recorded. All subjects are followed until death or lost to follow up. ;
| 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 | |
| Recruiting |
NCT06192797 -
Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic 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 |
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 ®)
|