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NCT05251662
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
Phase 2 trial testing Sintilimab in Intrahepatic Cholangiocarcinoma in 90 participants. Status unknown.
13 January 2024
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 13 January 2022 |
| Primary completion | 13 January 2024 |
| Estimated completion | 13 January 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
- IBI305 — full drug profile →
- GEMOX — full drug profile →
Conditions studied
- Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
Adults 18 to 75, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543 -
Intrahepatic cholangiocarcinoma: Evolving role of neoadjuvant and targeted therapy.
Ghio M, Vijay A. · · 2023 · cited 9× · PMID 36823963 · DOI 10.14701/ahbps.22-110 -
Current and Future Therapeutic Targets for Directed Molecular Therapies in Cholangiocarcinoma.
Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 4× · PMID 38730642 · DOI 10.3390/cancers16091690 -
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 NCT05251662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sintilimab
Trials testing the same drug.
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- NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
- NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
Other recruiting trials for Intrahepatic Cholangiocarcinoma
Currently open trials in the same condition.
- NCT06990659 — Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC) · NA · recruiting
- NCT06910722 — Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy · NA · recruiting
- NCT07169734 — A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06664021 — Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperativ · Phase 2 · recruiting
- NCT06505486 — GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC · recruiting
Other Tianjin Medical University Cancer Institute and Hospital trials
Trials by the same sponsor.
- NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
- NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
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 NCT05251662 (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 Tianjin Medical University Cancer Institute and Hospital
- Last refreshed: 23 February 2022
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/NCT05251662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing