NCT05407519 A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
| NCT ID | NCT05407519 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-07-25 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2022-07-25 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with a histopathological or cytologically diagnosis of HCC 2. Subjects who have undergone a curative resection 3. High risk for HCC recurrence as protocol defined 4. No previous systematic treatment and locoregional therapy for HCC 5. Child-Pugh Score, Class A 6. ECOG performance status 0 or 1 7. Full recovery from surgical resection 8. Adequate organ function 9. Absence of major macrovascular invasion 10. No extrahepatic spread 11. Life expectancy of at least 6 months Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2. Evidence of residual, recurrent, or metastatic disease 3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations 4. History of hepatic encephalopathy 5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein 6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment 7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 8. Any active malignancy within 2 years prior to the start of treatment 9. Active or history of autoimmune disease 10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 11. Pregnant or lactating women
Contact & Investigator
Lianxin LIU secretary of the party committee
PRINCIPAL INVESTIGATOR
Anhui Provincial Hospital
Frequently Asked Questions
Who can join the NCT05407519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05407519 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05407519 currently recruiting?
Yes, NCT05407519 is actively recruiting participants. Contact the research team at liulx@ustc.edu.cn for enrollment information.
Where is the NCT05407519 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT05407519 clinical trial?
NCT05407519 is sponsored by Anhui Provincial Hospital. The principal investigator is Lianxin LIU secretary of the party committee at Anhui Provincial Hospital. The trial plans to enroll 40 participants.
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