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

• Sponsor: Zhongnan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05282433
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 32.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Targeted Therapy; Progression-free Survival	Drug: Surufatinib	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma:HCCSC C01 Trial
• Anticipated Study Start Date: Apr 16, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Research Group Patients with advanced hepatocellular carcinoma who had failed previous standard 1/2-line therapy and could not tolerate or reject existing therapies.	Drug: Surufatinib; Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma; Other Names: Anti-PD-1 mAb

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [up to 12 weeks]

   Progression-free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hopital of Wuhan University	Wuhan	Hubei	China	430070

Sponsors and Collaborators

• Zhongnan Hospital

Investigators

• Principal Investigator: Fuxiang Zhou, MD,PhD, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhou Fuxiang, Clinical Professor of Zhongnan Hospital, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT05282433
• Other Study ID Numbers: HCCSC H01
• First Posted: Mar 16, 2022
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 16, 2022