Phase II Study of Fruquintinib Combined With Sintilimab and TACE for Inoperable Primary Hepatocellular Carcinoma

NCT05971199 | Unknown Phase 2

• 1 other identifier: IRB-2021-385
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, interventional clinical trial is to evaluation of fruquintinib in combination with sintulimab and TACE for inoperable primary hepatocellular carcinoma for progression-free survival (PFS).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.

  1 year

Secondary Outcomes (5)

• Object response rate(ORR)

  Change from baseline tumor volume at 6 months

• Time to response(TTR)

  through study completion, an average of 1 year

• Disease control rate(DCR)

  1 year

• Overall survival(OS)

  1 year

• Time to progression(TTP)

  24 months

Study Arms (1)

treatment

EXPERIMENTAL

Fruquintinib+sintilimab+TACE

Drug: Fruquintinib; Drug: Sintilimab; Device: Transcatheter arterial chemoembolization（TACE）

Interventions

Fruquintinib DRUG

Fruquintinib:5 mg capsule orally once daily on day 1-21 in 28-day cycles；

treatment

Sintilimab DRUG

Sintilimab: 200 mg i.v. every 3 weeks

treatment

Transcatheter arterial chemoembolization（TACE） DEVICE

Transcatheter arterial chemoembolization（TACE）

treatment

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years, male or female;
• Patients diagnosed with primary hepatocellular carcinoma (HCC) based on clinical diagnosis or pathology;
• Patients diagnosed with Chinese stage IIb-IIIa according to the Primary Liver Cancer Diagnostic and Treatment Protocol (2019 version), and evaluated by the investigator to be unable to undergo surgical treatment, such as resection, ablation or liver transplantation;
• Imaging reports within 14 days prior to the intervention showed the presence of at least 1 target lesion measurable by CT or MRI, and the lesion is suitable for repeated accurate measurements;
• Child-Pugh liver function rating: grade A or better B (≤7 points);
• ECOG score: 0-1;
• all lesions amenable to phase 1 or 2 (fractionated TACE) TACE therapy;
• Good organ and bone marrow function. Blood count: WBC\>4. 0 × 109/L, Hb\>80g/L, PLT\>75 ×109/L, NEUT\>/ 1.5 × 109/L; coagulation function:International normalized (prothrombin time) ratio(INR) \<1.2; liver function indexes: serum albumin (ALB) \>3.5 g/dl, serum total bilirubin(TBIL) \<1.5 times the upper limit of normal value (excluding biliary obstruction), serum transaminases (ALT and AST)\<3 times the upper limit of normal value; renal function: serum myelin (CR) \<1.5 times the upper limit of normal value;
• Signed an informed consent form, were compliant and cooperated with the follow-up.

You may not qualify if:

• Hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrous lamellar hepatocellular carcinoma;
• With portal trunk or vena cava invasion;
• Having received interventional treatment such as TACE within 2 years
• Combined with medical contraindications that preclude any contrast-enhanced imaging (CT or MRI);
• Previous systemic therapy;
• Uncontrollable ascites, hepatic encephalopathy or bleeding esophagogastric fundic varices;
• Hypertension that cannot be reduced to within normal limits with antihypertensive medication (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg);
• Suffering from myocardial ischemia or myocardial infarction of grade II or higher, poorly controlled arrhythmia of grade II or higher myocardial ischemia or infarction, poorly controlled arrhythmia (QTc interval greater than or equal to 450 ms, QTc interval calculated in Fridericia metric).
• (calculated in Fridericia formula);
• History of gastrointestinal bleeding within the past 3 months or a clear tendency of gastrointestinal bleeding, such as: esophageal varices at risk of bleeding, locally active ulcer lesions, fecal occult blood (++);
• Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures
• HIV-infected patients;
• Those suspected of being allergic to the study drug;
• Other circumstances that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the study results.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Guoliang Shao

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

HMPL-013; sintilimab

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

• Guoliang Shao

  Zhejiang Cancer Hospital Hangzhou, Zhejiang, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Shao

CONTACT

+8613958183472; shaoguoliang666@hotmail.com

Hui Zeng

CONTACT

+8613989898089; zenghuiray@zjcc.org.com

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: Head of Department of Interventional Therapy

Model Details: fruquintinib+sintilimab+TACE

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 2, 2023
• Study Start: November 23, 2021
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

CN (1)