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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling
Phase 2

Conditions

Tumor Thrombosis
Radiotherapy
Hepatocellular Carcinoma
Tislelizumab

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06233981
NCC4247

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Radiotherapy and Tislelizumab
Experimental group
Description:
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.
Treatment:
Drug: Tislelizumab
Radiation: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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