Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence

NCT05545124 | Unknown Phase 2

• 1 other identifier: 2022-388
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the safety and preliminary efficacy of donafenib combined with tislelizumab in adjuvant therapy after radical surgical resection of primary hepatocellular carcinoma with high risk of recurrence.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence-free survival

  Ratio of patients from first treatment to disease recurrence within 1 year

  1 years

Secondary Outcomes (3)

• recurrence-free survival with surgical resection

  2 years

• overall survival

  up to 1 years

• adverse events

  up to 1 years

Study Arms (1)

Donafenib+Tislelizumab

EXPERIMENTAL

Donafenib+Tislelizumab

Drug: Donafenib + Tislelizumab

Interventions

Donafenib + Tislelizumab DRUG

Donafenib 100mg, BID+Tislelizumab 200mg, D1; q3w

Donafenib+Tislelizumab

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 old (including the threshold value), male or female;
• Received radical resection of liver cancer 4-8 weeks before enrollment;
• Pathologically diagnosed as hepatocellular carcinoma and assessed by the investigator to have a high risk of recurrence;
• No recurrence or metastasis was confirmed by imaging examination before enrollment;
• Child-Pugh score of liver function A;
• Eastern Cooperative Oncology Group (ECOG) physical status (PS) score of 0-1;
• The expected survival period is not less than 3 months;
• The doctor's decision to use Donafenib must be done before the patient is enrolled in the study;
• For HBV-infected patients, if HBV-DNA is ≥104copies/ml within 14 days before enrollment, they should take antiviral treatment (entecavir is recommended), and then enter the study when it drops to \<104copies/ml, and continue antiviral treatment and monitoring Liver function and serum HBV-DNA level;
• Have sufficient organ functional reserve
• Female patients with reproductive potential (referring to nonmenopausal or surgical sterilization), the serum pregnancy test results must be negative within 7 days before the administration of the study drug; female or male patients with reproductive potential, during the use of the study drug And within 60 days after the last dose, reliable contraceptive measures must be used;
• Patients are voluntarily enrolled, can provide written informed consent, and can understand and comply with the experimental protocol, taking medication and follow-up.

You may not qualify if:

• Pathologically diagnosed as mixed hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) or fibrolamellar hepatocellular carcinoma;
• Past or current patients with congenital or acquired immunodeficiency diseases;
• Active or previously recorded autoimmune diseases or inflammatory diseases, with vitiligo or asthma that has been completely resolved in childhood, without any intervention in adulthood can be included;
• Combined with other liver diseases, including uncontrolled alcoholic hepatitis or other hepatitis, decompensated liver cirrhosis, severe fatty liver, hereditary liver disease, liver atrophy, superior vena cava syndrome, portal hypertension.
• Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found during chest CT scan screening;
• Other malignancies within 5 years, unless the patient has received potentially curative treatment and there is no evidence of the disease within 5 years, but this time requirement (that is, within 5 years) does not apply to basal cell carcinoma of the skin that has been successfully resected , skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other in situ carcinoma patients;
• Have a history of serious mental illness in the past;
• Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.);
• Received major surgery within 4 weeks before enrollment (determined by the investigator);
• Patients who have received allogeneic stem cell or solid organ transplantation in the past, including patients after liver transplantation;
• Received other anti-tumor systemic therapy before enrollment, including other traditional Chinese medicines with anti-tumor indications, less than 2 weeks or 5 drug half-lives (whichever is longer) after the completion of the treatment and before the drug in this study. , or patients whose adverse events caused by preoperative treatment did not recover to ≤CTCAE grade 1;
• Received other adjuvant therapy after surgery (except antiviral therapy);
• Systemic immunosuppressive drug therapy has been used within 2 weeks before enrollment, or systemic immunosuppressive drug therapy is expected to be required during the study period
• Concomitant use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp) or drugs that affect drug metabolism;
• The patient is known or suspected to have a history of allergy to tyrosine kinase inhibitor (TKI) drugs and PD-1 drugs, or to the excipients of the study drug;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib; tislelizumab

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

• Jinxue Zhou

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinxue Zhou, Ph.D.

CONTACT

13837175001; zhoujx888@126.com

Zhengzheng Wang

CONTACT

13526638243; 253700193@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: September 19, 2022

Record last verified: 2022-09