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HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma

Study acronym: CCGLC-011
StatusRecruiting
PhasePhase 2
Started2023-12-30
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 26, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 20, 2026 → Sep 30, 2026
Enrollment reduced 14% 42 → 36 participants
See other at-risk trials from Tongji Hospital

Amendment history

2026-08-25
Study Status, Study Design, Contacts/Locations v7
Enrollment reopened
Enrollment reduced: 42 → 36 participants
Primary completion pushed: 2026-07-20 → 2026-09-30
Study sitesdetails revised at 1 of 1 site
2026-07-20
Study Status v6
Primary completion dateestimated 2026-06-30→confirmed 2026-07-20
Completion date2028-06-30→2028-07-20
Start date2023-12-07→2023-12-30
2026-05-21
Study Status, Study Design, Contacts/Locations v5
Enrollment target44→42
2026-04-21
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-12-31→2026-06-30
Completion date2027-06-30→2028-06-30
Enrollment targetestimated 36→confirmed 44
InterventionsHAIC (Procedure), Lenvatinib plus cadonilimab (Drug)→Cadonilimab (Drug), Hepatic arterial infusion chemotherapy (HAIC-FOLFOX) (Procedure), Lenvatinib (Drug)
Eligibility criteria-4,251 characters
Inclusion Criteria: hepatocellularHepatocellular carcinoma is proven on biopsy or confirmed by the presence of radiological hallmarks, according to the American Association for the Study of Liver Diseases (AASLD) or the European Association for the Study of the Liver (EASL) guidelines. Age ≥18 years. Eastern Cooperative Oncology Grou [...] (ECOG) performance status score of 0 or 1. Not suitable for radicalcurative-intent surgerytreatment (including radical hepatic resection, liver transplantation, or liver cancercurative ablation) after evaluation by the hepatobiliary tumor MDT e [...] lowing conditions are [...]
Secondary endpoints10 to 14 entries
overallCurative-intent intervention rate Overall response rate (ORR) measuredby mRECIST Overall response rate (ORR) by RECIST 1.1 Disease control rate (DCR) by mRECIST Disease criteriacontrol rate (DCR) by RECIST 1.1 Progression-free survival (PFS) by mRECIST Time to progression (TTP) by mRECIST Time to intrahepatic tumor progressionresponse (TTITPTTR) Incidence ofby Study-Related Adverse Events Disease control rate (DCR)mRECIST Duration of response (DoR) by mRECIST QualityIncidence of Lifetreatment-related adverse events (QoLTRAEs) Major afterpathological response (MPR) Exploratory tissue and [...] [...]
Primary endpoints1 entry, revised
NumberConversion of Patients Amendable to Curative Surgical Interventionsrate
Study description+28 characters
Cadonilimab is the world's first PD-1/CTLA-4 bispecific antibody tumor immunotherapy new drug, a tetrameric PD-1/CTLA-4 bispecific antibody, which can only bind to TIL tetravalent co-expressing PD-1 and CTLA-4. This design not only retains the efficacy observed in the combination therapy of PD-1 plu [...] Hepatocellular carcinoma is underwayfrequently diagnosed at an unresectable stage, and preliminaryeffective resultsconversion revealstrategies thatare inneeded 30to enrolled patients,increase the ORR was 44.4%, the DCR was 77.8%, the treatment-related adverse reaction rate was 83.3%, but the inciden [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title+2 characters
Combined HAIC, Lenvatinib, and Cadonilimab Asas Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma
2024-12-07
Study Status, Eligibility v3
Eligibility criteria+221 characters
[...] n 40% of the total volume, or ICG-R15>15%. BCLC stage B or C: ①Multinodular HCC with Well defined nodules, preserved portal flow, selective access; ②Diffuse, infiltrative, extensive bilobar liver involvement; ③Portal invasion; ④>3 nodules or ≤3 nodules with at least one nodule>3cm. No prior systemic anti-tumor treatment for hepatocellular [...]
Show 2 earlier versions
2024-11-01
Study Status, Eligibility v2
Re-verified, no change to tracked fields
2024-10-11
Study Identification, Study Status, Sponsor/Collaborators, Oversight, IPDSharing v1
Completion date2026-06-30→2027-06-30
Start date2023-12-01→2023-12-07
Collaborators1 entry, revised
Geneplus-Beijing Co. Ltd.Akesobio
Study titlerevised
Combined HAIC, Lenvatinib and Cadonilimab asAs Conversion Therapy for Unresectable Hepatocellular Carcinoma
2023-12-17
Original filing
Tongji Hospital
197 trials monitored
See 2 trials at risk
Liver Cancer
1,505 trials monitored
See 60 trials at risk
This is an open-label, single-arm, phase 2 study evaluating hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and cadonilimab as conversion therapy for initially unresectable hepatocellular carcinoma (HCC). The primary objective is to assess the conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Secondary objectives include curative-intent intervention rate, tumor response, survival outcomes, safety, pathological response, and exploratory tissue and blood biomarkers.
Trial Details
NCT Number NCT06187961
Lead Sponsor Tongji Hospital
Collaborators: Akesobio
Conditions Hepatocellular Carcinoma Non-resectable
Enrollment 36 participants
Start Date 2023-12-30
Primary Completion 2026-09-30 (estimated)
Study Completion 2028-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-26