Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

NCT04996459 | Unknown

• 1 other identifier: GWK-2020-06
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40; Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:

1. 1.Age ≥18 years old;
2. 2.Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. 3.Plan or have received systemic therapy combined with Tiralizumab;
4. 4.No participation in other clinical studies;
5. 5.Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  overall response rate

  6 weeks

Secondary Outcomes (4)

• disease control rate

  6 weeks

• progress free survival

  6 weeks

• overall survival

  6 weeks

• Safety (the incidence of adverse events and serious adverse events)

  3 weeks

Study Arms (1)

Tislelizumab group

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Tislelizumab 200mg iv q3w

Tislelizumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients registrated and treated with Tislelizumab at least once were included in the efficacy analysis population as well as the safety analysis population.

This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements: 1. Age ≥18 years old; 2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis; 3. Plan or have received systemic therapy combined with Tislelizumab; 4. No participation in other clinical studies; 5. Access to Tislelizumab treatment and other clinical records.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

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

• Lu Wang, M.D.

  FUSCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: March 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 1, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CN (1)