Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular

This study is a prospective, randomized controlled, phase II trial evaluating the efficacy and safety of neoadjuvant therapy with Sintilimab combined with SBRT in patients with resectable hepatocellular carcinoma. After meeting the inclusion and exclusion criteria and providing informed consent, eligible subjects will be randomly assigned to the experimental group or the control group: * Experimental Group: Subjects will receive Sintilimab 200 mg via intravenous infusion on day 1 of each 3-week cycle, for a total of two cycles. This will be combined with SBRT, administered as 8 Gy per fraction for 3 fractions on days 1, 3, and 5. Surgery will be performed 4-6 weeks after the last treatment, following the assessment of the patient's condition. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year. * Control Group:Subjects will undergo surgery directly. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year.

Participants needed: 110
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Lei ZHAOUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Written informed consent must be provided and signed prior to the implementation... [+15]

History of any histologically/cytologically confirmed malignancy other than HCC. [+17]

Status: Recruiting

Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC

This study is a single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma. After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group: * Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks. Lenvatinib 8 mg was orally administered once daily, combined with the HAIC-FOLFOX regimen. After two cycles, the patients' conditions were evaluated for surgery. * Subjects in the control group underwent surgery directly. Both groups of subjects received sintilimab monotherapy as adjuvant treatment for half a year (a total of 8 cycles) after surgery. The treatment was terminated if there was disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or other reasons stipulated in the protocol.

Participants needed: 40
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Lei ZHAOUpdated: Apr 1, 2025Locations: 1
Eligibility criteria

Sign a written informed consent before the implementation of any trial-related p... [+9]

Previously histologically/cytologically confirmed liver cancer with components s... [+28]

Status: Recruiting

Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are: How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery. Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Lei ZHAOUpdated: Apr 17, 2024Locations: 1
Eligibility criteria

1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma; [+16]

1. Patients who received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors before enrollm... [+12]