A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Observational
SUMMARY

This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• Be willing and able to enrollment in this study, signing the informed consent form;

• Age between 18 and 75 years old, male or female patients;

• Child-Pugh class A;

• Indocyanine green 15 min retention rate (ICGR-15) \<15%;

• ECOG score 0-1;

• Diagnosis of hepatocellular carcinoma according to the Chinese HCC Diagnosis and Treatment Guidelines 2022 Edition and expected survival time greater than 4 months.

• Patients with a diagnosis of initial unresectable HCC (BCLC stage B or C), evaluated as partial response (PR) or stable disease (SD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combination with Sintilimab. The number of residual active lesions in the liver was 1 to 3 and suitable for radiation therapy. Fusion lesions in the liver were considered as 1 lesion, and portal vein cancer thrombus was considered as 1 lesion for treatment.

• Normal tissue limits were performed according to the UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy.

• Patients who have not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;

⁃ Patients with at least one measurable lesion according to RECIST 1.1 criteria (measurable lesion CT/MRI scan length diameter ≥10mm, and measurable lesion has not received localized treatments such as radiotherapy, cryotherapy, etc.);

⁃ Blood routine: absolute neutrophil count ≥1.5×10\^9/L, Hb ≥8.5g/L, PLT ≥75×10\^9/L;

⁃ No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance \>40 mL/min;

⁃ Women of childbearing age should agree that they must use contraception during and for 6 months after the end of the dosing period; patients who have had a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating, and men should agree that they must use contraception during and for 6 months after the end of the study period.

Locations
Other Locations
China
First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Fujian provincial hospital
NOT_YET_RECRUITING
Fuzhou
Fujian Provincial Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Contact Information
Primary
Shao-Ming Wei
67468424@qq.com
(+86)13599037493
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 28
Treatments
Triple Therapy sequential Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Fujian Provincial Hospital

This content was sourced from clinicaltrials.gov