Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples

NCT05171439 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-H104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center, open-label phase II study designed to assess the efficacy of surufatinib in participants with advanced hepatocellular carcinoma based on single-cell sequencing of tumor samples.

Conditions

Hepatocellular Carcinoma

Keywords

Surufatinib; single-cell sequencing

Outcome Measures

Primary Outcomes (1)

• Bioinformatics analysis of single-cell sequencing in hepatocellular carcinoma

  Analysis of HCC molecular biology information using single cell sequencing technology.

  approximately 1 years

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  approximately 1 years

• Objective response rate (ORR)

  approximately 1 years

• Disease control rate (DCR)

  approximately 1 years

• adverse events(AE)

  approximately 1 years

Study Arms (1)

Surufatinib

EXPERIMENTAL

All subjects will receive study treatment in 28-day cycle, Surufatinib 300mg, orally, QD , the treatment will continue until one of the following conditions occurs: progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first.

Drug: Surufatinib

Interventions

Surufatinib DRUG

Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Also known as: HMPL-012

Surufatinib

Eligibility Criteria

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

You may qualify if:

• Ages: 18-75 Years（concluding 18 and 75 Years）;
• Radiologically, histologically or cytologically confirmed hepatocellular carcinoma (HCC) with punctable lesions;
• Barcelona Clinic Liver Cancer stage Category B or C
• ECOG PS 0-1, there was no deterioration within 7 days;
• Liver function status Child-Pugh Class A or B (score≤7)
• Has life expectancy of greater than 12 months；
• HCC patients who received first-line standard chemotherapy (systemic chemotherapy with single or combination drugs such as oxaliplatin) and/or molecular targeted therapies such as sorafenib that failed or were not tolerated;
• Have measurable lesions (according to RECIST 1.1);
• The main organ functions meet the following criteria: (without blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment): Absolute Neutrophil Count (ANC)≥1.5×109/L Platelet Count of ≥100×109/L； Hemoglobin≥90g/L； Total Bilirubin (TBIL)≤1.5 x ULN； ALB≥29 g/L； ALT、AST and ALP≤5 x ULN； Creatinine（Cr）≤1.5×ULN (or creatinine clearance (CCr)≥ 60mL/min); (Only one of albumin and bilirubin in child-Pugh score can be 2 points)
• Male or females patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injected birth control medication or intrauterine device, during the study and within 90 days after study treatment discontinuation. All female patients are considered to be fertile, unless the patient had natural menopause or artificial menopause or sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation).
• Good compliance and follow-up

You may not qualify if:

• Hepatobiliary duct cell carcinoma and mixed cell carcinoma and fibrolaminar cell carcinoma；
• Patients who intend to undergo liver transplantation (except those who have previously undergone liver transplantation) ;
• Patients who have previously received surufatinib；
• Received investigational treatments in other clinical studies within 4 weeks prior to enrollment;
• Use of approved systematic anti-tumor therapy within 4 weeks prior to the first dose, including chemotherapy, biotherapy, targeted therapy (the washout period of small molecular targeted drugs lasts 2 weeks or 5 half-lives, whichever is shorter), hormone therapy, treatments with traditional Chinese medicine (for patients receiving treatments with traditional Chinese medicine with clear anti-tumor indications, for anti-tumor indications clearly specified in the package insert, one-week washout period prior to the first dose is acceptable), etc;
• Received any surgical or invasive treatment or operation (except intravenous catheterization, abdominal puncture and drainage, etc.) within 4 weeks before enrollment;
• International normalized ratio(INR) \>1.5 or activated partial thromboplastin time(APTT) \>1.5×ULN;
• Presence of clinically significant electrolyte abnormality judged by the investigator;
• Hypertension that is not controlled by the drug, and is defined as: SBP ≥140 mmHg and/or DBP ≥90 mmHg；
• With any diseases or conditions prior to enrollment that affected drug absorption, or patients could not take drugs orally;
• Drugs containing St John's wort taken within 3 weeks prior to the first study treatment, or other strong inducers with CYP3A4 or strong inhibitors taken within two weeks prior to the first study treatment;
• Have a gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation, according to the investigator's judgement；
• Patients with evidence or history of obvious bleeding tendency within 3 months before enrollment (\>30 ml within 3 months, appeared hematemesis, black dung, hematochezia ) or Hemoptysis (\>5 mL of fresh blood within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attacks) within 12 months;
• Have clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction; severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure according to the New York Heart Association (NYHA) classification ≥ 2; ventricular arrhythmias which needs drug treatment; or left ventricular ejection fraction (LVEF) \<50%;
• Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum tower hospital

Nanjing, Jiangsu, 210009, 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

Central Study Contacts

shiping jiao, PhD

CONTACT

17368691876; jiaoshp@tcrximmune.cn

Wenbo Du, PhD

CONTACT

du-wenbo@qq.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: Director, Hepatobiliary Surgery

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 29, 2021
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)