Clinical trial · Interventional
Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure
Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail
NCT06413017CI-TRIAL-00077131unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
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 |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICIs(Immune checkpoint inhibitors) | Drug | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimtuzumab combined ICIs
- description
- Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment
- interventionNames
- Drug: Nimotuzumab
- Drug: ICIs(Immune checkpoint inhibitors)
Primary outcomes (1)
- measure
- ORR（Objtective reseponse rate）
- timeFrame
- up to 24 month
- description
- （Objtective reseponse rate）
Secondary outcomes (2)
- measure
- OS（overall survival）
- timeFrame
- up to 24 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma； * Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)； * Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ; * Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC; * Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1； * EGFR postive and RAS wildtype； Exclusion Criteria: * Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma； * History of hepatic encephalopathy within 6 months prior to the first dose of this study； * Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose； * Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
References
Publications (0)
Data not yet available
No reference posted for this study.