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NCT07304388
HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC
Phase 2 trial testing hepatic arterial infusion chemotherapy (HAIC) in Intrahepatic Cholangiocarcinoma (Icc) in 96 participants. Completed in 1 June 2025.
1 April 2025
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 10 February 2023 |
| Primary completion | 1 April 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- hepatic arterial infusion chemotherapy (HAIC) — full drug profile →
- Chemotherapy (chemotherapy) — full drug profile →
Conditions studied
- Intrahepatic Cholangiocarcinoma (Icc) — all drugs for Intrahepatic Cholangiocarcinoma (Icc) →
Sponsor
Sun Yat-sen University
Who can join
18 and older, any sex, with Intrahepatic Cholangiocarcinoma (Icc). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC. Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07304388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of hepatic arterial infusion chemotherapy (HAIC)
Trials testing the same drug.
- NCT07353827 — FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarc · Phase 2 · not yet recruiting
- NCT07062055 — BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases · Phase 2 · recruiting
- NCT06859684 — Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced · Phase 2 · recruiting
- NCT06988852 — FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis · Phase 2 · recruiting
- NCT07368530 — Using Machine Learning to Identify Responders to TACE or HAIC for uHCC · completed
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 Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet 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 NCT07304388 (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 Sun Yat-sen University
- Last refreshed: 30 December 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/NCT07304388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing