Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis

NCT06233981 | Completed Phase 2

• 1 other identifier: NCC4247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.

Conditions

Hepatocellular Carcinoma; Radiotherapy; Tislelizumab; Tumor Thrombosis

Keywords

Hepatocellular Carcinoma; Radiotherapy; Tislelizumab; Tumor Thrombosis

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival

  Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the end of radiotherapy to death from any cause

  24 months

Secondary Outcomes (3)

• Objective Response Rate

  Assessment in 1 to 3 months after radiotherapy

• Progression-free Survival

  24 months

• Toxicity

  up to 24 months

Study Arms (1)

Radiotherapy and Tislelizumab

EXPERIMENTAL

Moderate-dose hypofractionated intensity-modulated radiotherapy with a gross tumor dose of 25Gy/5f and a maximum dose of 35Gy/5f at the tumor center concurrent with Tislelizumab, followed Tislelizumab±lenvatinib for maintenance.

Radiation: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy; Drug: Tislelizumab

Interventions

Moderate-dose Hypofractionated Intensity-modulated Radiotherapy RADIATION

All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center.

Radiotherapy and Tislelizumab

Tislelizumab DRUG

One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab, which may be escalated up to a maximum of 12 mg per day, until disease progression or intolerance or death.

Radiotherapy and Tislelizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical or histological diagnosis of HCC with bilateral PVTT;
• Estimated Liver-GTV volume \< 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation \< 300ml;
• Age 18-90 years;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Child-Pugh A5, A6, B7 and B8;
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN); or ALT ≤ 1.5 times ULN and AST ≤ 6 times ULN; TBIL \< 60umol/L.
• Creatinine (CRE) and blood urea nitrogen (BUN) \< 2.5 ULN;
• Hb ≥ 50g/L, ANC ≥ 0.5 × 109/L, PLT ≥ 30 × 109 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L;
• \. Voluntary to participate and sign informed consent.

You may not qualify if:

• Participating in other clinical trials currently;
• The history of abdominal irradiation;
• The history of liver transplantation;
• Known allergy to tislelizumab or lenvatinib;
• Pregnant, breast feeding, or unwilling to use adequate contraception;
• Serious myocardial disease or renal failure;
• Other serious diseases, such as alcohol and drug abuse or mental illness;
• Presence of other life-threatening malignancy within the last 3 years before enrollment (excluding superficial skin cancer, localized low-grade malignant tumor and carcinoma in situ).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College

Beijing, 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 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: Professor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 31, 2024
• Study Start: January 25, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2024-01

Locations

CN (1)