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NCT05738057
Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma
Phase 2 trial testing Camrelizumab in Unresectable Intrahepatic Cholangiocarcinoma in 22 participants. Status unknown.
1 March 2025
Quick facts
| Lead sponsor | Hua Li |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 30 June 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Camrelizumab — full drug profile →
- Gemcitabine Injection
- Cisplatin injection — full drug profile →
- Cisplatin-Eluting Beads — full drug profile →
- D-TACE — full drug profile →
Conditions studied
- Unresectable Intrahepatic Cholangiocarcinoma — all drugs for Unresectable Intrahepatic Cholangiocarcinoma →
Sponsor
Hua Li — full company profile →
Who can join
18 and older, any sex, with Unresectable Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are: * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable. * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Update on Locoregional Therapies for Cholangiocellular Carcinoma.
Morawitz J, Bruckmann NM, Jannusch K, Kirchner J, et al · · 2023 · cited 5× · PMID 37190295 · DOI 10.3390/cancers15082368 -
Conversion treatment for advanced intrahepatic cholangiocarcinoma: Opportunities and challenges.
Liu JJ, Zhou M, Yuan T, Huang ZY, et al · · 2025 · cited 3× · PMID 40309227 · DOI 10.3748/wjg.v31.i15.104901 -
Conversion therapy for unresectable intrahepatic cholangiocarcinoma using gemcitabine plus S-1 combined with PD-1 inhibitors: a case report.
Zhao S, Zhang X, Luo J, Yan H, et al · · 2024 · cited 1× · PMID 39882451 · DOI 10.3389/fonc.2024.1476593
Verify or expand the search:
- PubMed search for NCT05738057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Hua Li trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05738057 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hua Li
- Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05738057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing