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Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients

Efficacy and Safety of Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients

NCT06370065•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing to attend the study and having given the ICF
•2. Age ≥18
•3. Have a HCC diagnosis confirmed by radiology, histology, or cytology HCC is diagnosed at Barcelona Clinic Liver Cancer (BCLC) Stage C
•4. Have not accepted any of systemic therapy for HCC such as systemic chemotherapy, molecular targeted drugs, immunotherapy.
•5. At least 1 measurable intrahepatic lesion suitable for repeat assessments according to RECISTv1.1 criteria and it has not undergone surgery, radiology and/or other regional therapy (including but not limited to radiofrequency ablation, percutaneous ethanol injection, freezing therapy, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization). But if it progressed after the regional therapy, it could be selected as a target lesion. The local regional therapy must be done 4 weeks before randomization and the related AEs must recover to ≤ CTCAE grade 1.
•6. Child-Pugh score ≤7
•7. Eastern Cooperative Oncology Group (ECOG) 0 or 1
•8. Expected life time is over 12 weeks.
•9. HBV-DNA \< 2000 IU/mL
•10. Organs function:
+1 more criteria

Exclusion Criteria

•1. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
•2. History of hepatic encephalopathy
•3. History of GI bleeding within 6 months, or investigator defined with high risk of haemorrhage for esophageal varices
•4. With distant metastasis (hilar lymph nodes metastasis is allowed)
•5. Co-infection of HBV and HCV
•6. History of other malignancy within 5 years except for healed local tumor.
•7. History of or plan to accept allogenic organ transplantation
•8. Ascites requiring invasive intervention (e.g. paracentesis) to maintain symptomatic control (every month or more often)
•9. History of myocardial infarction or unstable angina or uncontrolled arrythmia or stroke or cerebral hemorrhage within 6 months prior to randomization. QTcF value ≥450ms（male）or ≥470ms（female） detected by 12-lead electrocardiogram.
•10. New York Heart Association Grade ≥2 congestive heart failure or LVEF \<50%
+17 more criteria

Locations (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

April 27, 2023

Primary Completion Date

June 30, 2024

Completion Date

December 31, 2024

Last Updated

April 17, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Hepatocellular Carcinoma

Interventions

HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）

DRUG

Contacts

Huikai Li, MD

CONTACT

18622228639 tjchlhk@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients

Inclusion Criteria

Exclusion Criteria

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