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

NCT05282433 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC H01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma; Targeted Therapy; Progression-free Survival

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival

  up to 12 weeks

Study Arms (1)

Research Group

EXPERIMENTAL

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

Drug: Surufatinib

Interventions

Surufatinib DRUG

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

Also known as: Anti-PD-1 mAb

Research Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• 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.
• The patients had mental disorders, and the researchers believed that the patients could not fully or fully understand the possible complications in this study.
• Have a history of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430070, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Fuxiang Zhou, MD,PhD

  Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuxiang Zhou, MD,PhD

CONTACT

+86-027-67813155; fuxiang.zhou@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Zhongnan Hospital

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: April 16, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

CN (1)