Clinical Trials Logo

Clinical Trial Summary

Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.

Clinical Trial Description

This is a perspective, single-arm trial. According to previous studies, the PFS of HAIC for unresectable intrahepatic cholangiocarcinoma is approximately 8 - 10 months, and one year progression free rate is about 40%. We assumed that the study could detect 20% absolute difference and 1 year PFS rate could achieve 60% PFS by (FOLFOX + H101) over conventional HAIC (FOLFOX). Simon's two-stage design is used to estimate the sample size, with α value of 0.05 and power of 0.9. A total sample size of 66 participants are required. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05124002
Study type Interventional
Source Beijing Tsinghua Chang Gung Hospital
Phone 0086-13969193950
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date December 3, 2021
Completion date December 3, 2024

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
Not yet 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
Recruiting 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 NCT04782804 - PD-1 Antibody(Tislelizumab) Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection Phase 1/Phase 2
Recruiting NCT04264260 - Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment Phase 2
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 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 ®)