Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT05282433

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-16
• Study Completion Date: 2024-12-31

Brief Summary

This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of surufatinib alone or combined with Anti-PD-1 mAb in the treatment of advanced Hepatocellular Carcinoma

Detailed Description

This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of surufatinib alone or combined with Anti-PD-1 mAb in the treatment of advanced Hepatocellular Carcinoma.

Cohort A: patients with advanced hepatocellular carcinoma who had failed previous standard first-line therapy and could not tolerate or reject existing therapies.Treatment:surufatinib combined with Anti-PD-1 mAb Cohort B: patients with advanced pancreatic cancer who had previously failed standard sencond-line therapy, could not tolerate or reject existing therapies.Treatment:surufatinib alone.

Conditions

Hepatocellular Carcinoma; Targeted Therapy; Progression-free Survival

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Research Group

Patients with advanced hepatocellular carcinoma who had failed previous standard 1/2-line therapy and could not tolerate or reject existing therapies.

Group Type: EXPERIMENTAL

Surufatinib

Intervention Type: DRUG

Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma

Interventions

Surufatinib

Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma

Intervention Type: DRUG

Other Intervention Names

Anti-PD-1 mAb

Eligibility Criteria

Inclusion Criteria

• 1. 18 years to 75 years. 2.Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1)： Cohort A: patients with advanced hepatocellular carcinoma who had failed previous standard first-line therapy and could not tolerate or reject existing therapies.

Cohort B: patients with advanced hepatocellular carcinoma who had previously failed standard sencond-line therapy, could not tolerate or reject existing therapies.

3.Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥80g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate > 50ml/min).

4.At least 4 weeks after the last anti-tumor treatment (surgery, chemotherapy, radiotherapy, biotherapy or endocrine therapy) before enrollment.

5.Had a life expectancy of at least 3 months. 6.Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.

7.Signed informed consent.

Exclusion Criteria

• 1.In the past or at the same time with other malignant tumors (already cure period of IB or cervical, lower levels of noninvasive basal cell or squamous cell cancer, obtain complete remission (CR) > 10 years of breast cancer, obtain complete remission (CR) > 10 years of malignant melanoma, obtain complete remission (CR) > 5 years except of other malignant tumors).

2.Pregnant or lactating female patients. 3.Had a history of clinically significant or uncontrolled heart disease, including but not limited to: (1)Myocardial infarction. (2)Angina.(3)Congestive heart failure above grade 2 of the New York heart association (NYHA).(4)Ventricular arrhythmias requiring continuous treatment.(5)Supraventricular arrhythmias, including uncontrolled atrial fibrillation.

4.The patients had mental disorders, and the researchers believed that the patients could not fully or fully understand the possible complications in this study.

5.Have a history of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.

6.Those who cannot tolerate or may be allergic to the drugs used in this study. 7.Participated in clinical trials of other drugs within the past 1 month. 8.Other factors considered unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Fuxiang

Clinical Professor of Zhongnan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuxiang Zhou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuxiang Zhou, MD,PhD

Role: CONTACT

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Facility Contacts

Fuxiang Zhou, MD

Role: primary

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Other Identifiers

HCCSC H01

Identifier Type: -

Identifier Source: org_study_id