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

NCT ID: NCT06233981

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2026-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy and Tislelizumab

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.

Group Type: EXPERIMENTAL

Moderate-dose Hypofractionated Intensity-modulated Radiotherapy

Intervention Type: 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.

Tislelizumab

Intervention Type: 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 if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance.

Interventions

Moderate-dose Hypofractionated Intensity-modulated Radiotherapy

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.

Intervention Type: RADIATION

Tislelizumab

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;

2. Age 18-90 years;

3. Liver-GTV volume<700ml or the estimated volume of Liver-GTV receiving less than 5 Gy of irradiation<300ml but the average dose of Liver-GTV needs to be <18Gy;

4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies;

5. ECOG performance status 0-2, expected survival greater than 1 month;

6. Allowing patients with distant metastases;

7. Child-Pugh A5, A6, B7 and B8;

8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL <60umol/L.

9. No significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment;

10. CRE, BUN within 2.5 times the normal upper limit;

11. Hb ≥ 50g/L, ANC ≥ 0.5 × 10^9 /L, PLT ≥ 30 × 10^9 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L and a significant rising trend;

12. Patients voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria

1. Currently participating in other clinical trials;

2. Previously received abdominal radiotherapy or liver transplantation;

3. Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;

4. Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.

5. Suspected or confirmed drug addiction, medicine abuse,or alcoholism

6. Pregnant or lactating women;

7. Severe mental or neurological disorders

8. Presence of other life-threatening malignancy within the last 3 years before the start of the study (excluding superficial skin cancer, localized low-grade malignant tumor and in situ carcinoma).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

BO CHEN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bo Chen, MD

Role: primary

Other Identifiers

NCC4247

Identifier Type: -

Identifier Source: org_study_id