Clinical trial · Interventional
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.
Summary
Brief summary (as posted)
The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cTACE | Procedure | — | UNRESOLVED |
| IBI318 | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI318 combined with conventional TACE (cTACE)
- interventionNames
- Drug: IBI318
- Procedure: cTACE
- type
- PLACEBO_COMPARATOR
- label
- Placebo combined with conventional TACE (cTACE)
- interventionNames
- Procedure: cTACE
- Drug: placebo
Primary outcomes (1)
- measure
- Number of participants experiencing clinical and laboratory adverse events (AEs)
- timeFrame
- Up to 90 days post last dose
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 years and ≤ 75 years at the time of consent. 2. Hepatocellular carcinoma confirmed by histology/cytology. 3. Lesions with measurable disease at baseline by mRECIST. 4. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria. 5. Child-Pugh: \<=6 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. 2. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma. 3. Potential liver transplant candidates 4. Have a history of hepatic encephalopathy or have a history of liver transplantation. 5. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
References
Publications (0)
Data not yet available