Clinical study of TACE combined with lenvatinib plus sintilimab in the treatment of hepatocellular carcinoma with portal vein tumor thrombus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066830

Enrollment

Unknown

Registered

2022-12-19

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Treatment group:TACE combined with lenvatinib plus sintilimab

Control group:TACE combined with lenvatinib

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients receiving first-line treatment in Beijing Ditan Hospital, Capital Medical University; (2) Aged 18-75 years old; (3) Confirmed diagnosis of hepatocellular carcinoma, according to the 2011 diagnosis and treatment specifications or pathological diagnosis of primary liver cancer; (4) Abdominal magnetic resonance imaging or abdominal CT enhanced confirmed combined portal vein tumor thrombus I-IV type; (5) Liver function was Child-pugh A or B (= 7 points); (6) Basic normal organ function: WBC = 3.0 * 109/L, PLT = 70 * 109/L, Hgb = 80 * 109/L; ALT = 5ULN, AST = 5ULN, TBIL = 3ULN, ALB = 28 g/L; CCr = 80ml/min; (7) Non-radical surgery or liver transplantation indications; (8) Assessable target lesions (enhanced lesions greater than 1 cm on enhanced CT or MRI); (9) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Child-pugh class C or B > = 8; previous use of molecular targeted drugs, systemic chemotherapy or immunotherapy drugs including but not limited to the following drugs: sorafenib, lenvatinib, apatinib, regorafenib, PD-1 inhibitors or platinum-based or fluorouracil drugs systemic chemotherapy; (2) previous 1 month had received local radiation therapy or radiofrequency ablation therapy and other local treatment methods, only local treatment lesions, but the lesion did not progress; (3) symptomatic brain metastases; (4) active bleeding tendency; (5) uncontrolled hypertension; (6) combined with other incurable malignant tumors, except other sites of carcinoma in situ; (7) active infection; (8) heart failure or unstable angina pectoris, myocardial infarction within 1 year; (9) combined with active autoimmune diseases such as Sjogren 's syndrome, lupus erythematosus, etc.; (10) severe mental illness can not be informed consent or cooperate with this regimen; (11) the use of warfarin anticoagulant patients; (12) Other conditions contraindicated for TACE.

Design outcomes

Primary

Measure	Time frame
Time to Progression;	—

Secondary

Measure	Time frame
Overall Survival;Objective Response Rate;Safety;	—

Countries

China

Contacts

Public ContactJinglong Chen

Beijing Ditan Hospital, Capital Medical University

cjl6412@ccmu.edu.cn13671306391

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026