Canceled by the investigator. Clinical study on the first-line treatment of advanced hepatocellular carcinoma with B-grade liver function using lenvatinib combined with sintilimab and compared to donafenib combined with sintilimab

Clinical study on the first-line treatment of advanced hepatocellular carcinoma with B-grade liver function using lenvatinib combined with sintilimab and compared to donafenib combined with sintilimab

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076242

Enrollment

Unknown

Registered

2023-09-28

Start date

2023-09-30

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

hepatocellular carcinoma

Interventions

lenvatinib combined with sintilimab:lenvatinib combined with sintilimab

Donafenib combined with sintilimab:Donafenib combined with sintilimab

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with first-line treated HCC at three hospitals; 2. Aged 18-80 years; 3. Definite diagnosis of hepatocellular carcinoma (HCC) based on the 2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer or pathological confirmation; 4. Confirmation of portal vein tumor thrombus (type I-IV) by contrast-enhanced abdominal MRI or CT; 5. Child-Pugh B liver function classification (7-9 points); 6. Basic normal function of all organs; 7. Not eligible for curative surgery or liver transplantation; 8. Presence of assessable target lesions (enhancing lesions > 1 cm on contrast-enhanced CT or MRI); 9. Willingness to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Prior 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-containing or fluoropyrimidine-based systemic chemotherapy; 2. Receipt of local treatment such as radiotherapy or radiofrequency ablation within the past month, with only the lesions treated locally showing no progression; 3. Symptomatic brain metastases; 4. Active bleeding tendency; 5. Uncontrolled hypertension; 6. Concurrent untreated malignancies, excluding in situ cancers at other sites; 7. Active infections; 8. Heart failure or unstable angina, myocardial infarction within the past year; 9. Concurrent active autoimmune diseases such as Sjögren's syndrome, lupus, etc.; 10. Severe psychiatric disorders preventing informed consent or compliance with the treatment plan; 11. Use of anticoagulants like warfarin.

Design outcomes

Primary

Measure	Time frame
time to progression;	—

Secondary

Measure	Time frame
overall survival;Objective Response Rate;safety;	—

Countries

China

Contacts

Public ContactXiaoyan Ding

Beijing Ditan Hospital, Capital Medical University

dingxiaoyan198111@163.com+86 138 1156 0276

Outcome results

None listed

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