Clinical trial · Interventional
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
NCT06935175CI-TRIAL-00088723not yet recruitingPhase 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)
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
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 Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1826 | Drug | — | UNRESOLVED |
| SHR-1826 and immunotherapy combination therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-1826 monotherapy arm
- interventionNames
- Drug: SHR-1826
- type
- EXPERIMENTAL
- label
- SHR-1826 and immunotherapy combination therapy
- interventionNames
- Drug: SHR-1826 and immunotherapy combination therapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) by RECIST V1.1
- timeFrame
- up 2 years
- description
- The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1.18-75 years old, male or female. 2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery; 3.Failure of at least one line of standard treatment (progression or intolerance); 4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion); 5.Expected survival time ≥ 12 weeks; 6.Normal function of major organs; 7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up. Exclusion Criteria: 1. Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type); 2. Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.; 3. Have central nervous system metastasis; 4. Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation); 5. Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study; 6. Other situations in which the investigator deems that the subject should not be included.
References
Publications (0)
Data not yet available
No reference posted for this study.