NCT06089369Not yet recruitingPhase 3
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
Source: ClinicalTrials.gov · Last updated 30 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06089369
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 360
- From 1 Jun 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any preoperative treatment for HCC including local and systemic therapy
- Have received more than 1 cycle of adjuvant TACE following surgical resection
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
Other illness
- Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- Cardiac clinical symptom or cardiovascular disease that is not well controlled
- Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
Other
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
- Inability or refusal to comply with the treatment and monitoring
Who the study is looking for
- Subjects with a histopathological diagnosis of HCC
- Undergone a curative resection
- Pathologically confirmed HCC with microvascular invasion (MVI)
- Aged 18-75 years
- No previous systematic treatment and locoregional therapy for HCC prior to randomization
- Absence of major macrovascular invasion
- No extrahepatic spread
- Full recovery from Curative resection within 4 weeks prior to randomization
- Child-Pugh: Grade A or B(7)
- ECOG-PS score: 0 or 1
- Subjects with HCV- RNA (+) must receive antiviral therapy
- Adequate organ function
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.