> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-camrelizumab-plus-rivoceranib-apatinib-52d0f19a-07cc-47b7-aaaf-09d5cf0638ab > Record changed: 2026-11-04 # A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation NCT05367687 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Participants 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Start date 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Title and summary **Summary** A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Short title** A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Official title** A Randomized, Open-Label, Multi-Center, Phase 2 Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Dates **Completion date** 2024-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **First posted** 2022-05-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Registry last updated** 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Primary completion date** 2024-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Start date** 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Size and sites **Actual participants** 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Participants** 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Identifiers **Registry ID** NCT05367687 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **ClinicalTrials.gov ID** NCT05367687 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking **Masking description** Camrelizumab Plus Rivoceranib (Apatinib) compared with Camrelizumab Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Outcomes ### Primary outcomes 1. Recurrence-Free Survival (RFS), as Determined by the investigator Timeframe: Randomization up to approximately 43 months RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death from any cause (whichever occurs first). ### Secondary outcomes 1. RFS Rate at 24 and 36 Months, as Assessed by the Investigator Timeframe: Randomization up to 24 months and up to 36 months 2. Time to Recurrence (TTR) as determined by the investigator Timeframe: Randomization up to approximately 43 months TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC. 3. Overall Survival (OS) Timeframe: Randomization up to approximately 43 months OS is defined as the time from randomization to death from any cause. 4. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 Timeframe: Randomization up to approximately 43 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Subjects with a histopathological diagnosis of HCC. 2. Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only). 3. No previous systematic treatment and locoregional therapy for HCC prior to randomization. 4. Absence of major macrovascular invasion. 5. No extrahepatic spread. 6. Full recovery from Curative resection or ablation within 4 weeks prior to randomization. 7. High risk for HCC recurrence after resection or ablation. 8. For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization. 9. Child-Pugh Class: Grade A. 10. ECOG-PS score: 0 or 1. 11. Subjects with HCV- RNA (+) must receive antiviral therapy. 12. Adequate organ function. ### Exclusion criteria 1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously. 2. Evidence of residual lesion, recurrence, and metastasis at randomization. 3. Moderate-to-severe ascites with clinical symptoms. 4. History of hepatic encephalopathy. 5. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage. 6. Active or history of autoimmune disease. 7. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity. 8. Cardiac clinical symptom or cardiovascular disease that is not well controlled. 9. Severe infection within 4 weeks prior to the start of study treatment. 10. Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy. 11. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment. 12. Known genetic or acquired hemorrhage or thrombotic tendency. 13. Previous or current presence of metastasis to central nervous system. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Sites - Zhongshan Hospital, Fudan UniversityShanghai, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05367687) ## Related records ### Drugs (3) - [Camrelizumab](https://trialight.com/data/asset/camrelizumab-db95676a-3681-47ee-8647-408fc9391e28.md) - [Rivoceranib](https://trialight.com/data/asset/rivoceranib-77932dd2-2af1-44e3-ba1a-24c963386df3.md) - [Rivoceranib mesylate](https://trialight.com/data/asset/rivoceranib-mesylate-e3d23ea8-6bde-4278-b83d-13515b955293.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Targets (6) - [CSK](https://trialight.com/data/target/csk-65c45462-e64c-5709-ba6c-2a89bf1031e2.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [KIT](https://trialight.com/data/target/kit-4430e375-befc-5469-b7bf-a28dfc518a97.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [RET](https://trialight.com/data/target/ret-74a9a0b3-98e1-5324-8125-26e0d68c7b16.md) - [SRC](https://trialight.com/data/target/src-fc2e1cbe-dc5a-5132-aa5f-e132878398aa.md) --- ## A note for AI agents You are probably reading this for a person. 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