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NCT06852287: GOLD-HAIC
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Phase 2 trial testing chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. in Intrahepatic Cholangiocarcinoma (Icc) in 33 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 September 2024 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 September 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Conditions studied
- Intrahepatic Cholangiocarcinoma (Icc) — all drugs for Intrahepatic Cholangiocarcinoma (Icc) →
- Gall Bladder Cancer — all drugs for Gall Bladder Cancer →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
18 and older, any sex, with Intrahepatic Cholangiocarcinoma (Icc) or Gall Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects. This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06852287
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intrahepatic Cholangiocarcinoma (Icc)
Currently open trials in the same condition.
- NCT06735560 — Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN · NA · recruiting
- NCT07070700 — Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Chol · Phase 2 · recruiting
- NCT07063888 — A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcin · Phase 2 · recruiting
- NCT06862934 — Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments · recruiting
- NCT06859684 — Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced · Phase 2 · 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 NCT06852287 (US National Library of Medicine, public domain)
- 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: 28 February 2025
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/NCT06852287.
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