NCT05535647 is a Phase 2 clinical trial of Regorafenib and HAIC in Intrahepatic Cholangiocarcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital.

Who is sponsoring NCT05535647?

NCT05535647 is sponsored by Tianjin Medical University Cancer Institute and Hospital.

What drugs are being tested in NCT05535647?

Interventions in NCT05535647: Regorafenib and HAIC, FOLFOX.

What condition does NCT05535647 study?

NCT05535647 studies Intrahepatic Cholangiocarcinoma.

Is NCT05535647 still recruiting?

NCT05535647 is currently status unknown. Last updated 10 September 2022.

Last reviewed 2022-09-10 · How we verify

NCT05535647

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Status unknown Phase 2 Last updated 10 September 2022

What this trial tests

Phase 2 trial testing Regorafenib and HAIC in Intrahepatic Cholangiocarcinoma in 60 participants. Status unknown.

Timeline

25 September 2022

Primary endpoint
25 September 2024

25 September 2025

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	single
Primary purpose	treatment
Enrollment	60
Start date	25 September 2022
Primary completion	25 September 2024
Estimated completion	25 September 2025
Sites	1 location across China

Drugs / interventions tested

Regorafenib and HAIC — full drug profile →
FOLFOX (folfox) — 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

This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05535647 (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: 10 September 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/NCT05535647.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing