Clinical trial · Interventional
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
- 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 randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
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 |
|---|---|---|---|
| Locally Advanced or Metastatic and Unresectable HCC | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| SHR-1210 | Drug | Camrelizumab | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-1210
- description
- SHR-1210+Apatinib
- interventionNames
- Drug: SHR-1210
- Drug: Apatinib
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Sorafenib
- interventionNames
- Drug: Sorafenib
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Up to approximately 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically or cytologically confirmed advanced HCC * No previous systematic treatment for HCC * Have at least one measurable lesion (in accordance with RECIST v1.1) * BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy * ECOG-PS score 0 or 1 * Child-Pugh Class: Grade A * Life Expectancy of at least 12 weeks * Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study * Subjects with HCV-RNA(+) must receive antiviral therapy * Adequate organ function Exclusion Criteria: * Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously * Moderate-to-severe ascites with clinical symptoms * History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage * Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * Known genetic or acquired hemorrhage or thrombotic tendency * Thrombosis or thromboembolic event within 6 months prior to the start of study treatment * Cardiac clinical symptom or disease that is not well controlled * Hypertension that can not be well controlled through antihypertensive drugs * Factors to affect oral administration * History of hepatic encephalopathy * Previous or current presence of metastasis to central nervous system * HIV infection * Combined hepatitis B and hepatitis C co-infection * Be ready for or previously received organ or allogenic bone marrow transplantation * Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity * Active known, or suspected autoimmune disease * Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment * Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF * Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * Severe infection within 4 weeks prior to the start of study treatment * Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment * Treatment of other investigational product(s) within 28 days prior to the start of study treatment
References
Publications (2)
- DERIVEDQin S, Gu S, Chan SL, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Xu L, Yuan X, Li D, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Du J, Shi W, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): final analysis of a randomised, open-label, international, phase 3 study. Lancet Oncol. 2025 Dec;26(12):1598-1611. doi: 10.1016/S1470-2045(25)00543-1. PMID 41308676
- DERIVEDQin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24. PMID 37499670