Hepatocellular Carcinoma
Conditions
Interventions
Control Group:Postoperative active surveillance and monitoring
Treatment Group:Postoperative adjuvant radiotherapy combined with sintilimab
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 and =75 years; 2.ECOG PS: 0–1; 3.No prior antitumor therapy before surgery; 4.Underwent curative resection, with curative intent confirmed within 1–2 months postoperatively via pathological report, contrast-enhanced CT/MRI, and tumor marker levels; 5.Child–Pugh grade A liver function; 6.Postoperative pathological confirmation of hepatocellular carcinoma with narrow resection margins; 7.Confirmed single tumor by preoperative imaging and postoperative pathology; 8.Baseline hematological and biochemical parameters meeting the following criteria: Hemoglobin =90 g/L, Absolute neutrophil count (ANC) =1.5 × 10?/L, Platelets =75 × 10?/L, ALT and AST =3 × upper limit of normal (ULN), Total bilirubin =1.5 × ULN, Serum creatinine =1.5 × ULN, Serum albumin =30 g/L 9.Female patients must meet at least one of the following: Postmenopausal (defined as =1 year of amenorrhea without other known causes), or Surgically sterile (with removal of ovaries and/or uterus), or Of childbearing potential, provided: A negative serum pregnancy test within 7 days before randomization, Agreement to use a highly effective contraceptive method (with annual failure rate <1%) or practice abstinence from the time of signing informed consent until at least 150 days after the last dose of study drug. Highly effective methods include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 10.Male patients must agree to the following: Abstain from heterosexual intercourse or use condoms during the treatment period and for at least 150 days after the last dose of study drug when their partner is a woman of childbearing potential or is pregnant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable forms of contraception. 11.The subject voluntarily agrees to participate in the study, signs the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) History or current diagnosis of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; (2) Previous treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 agents) or other T-cell receptor–targeting drugs for any condition; (3) Active autoimmune disease requiring systemic treatment within the past 2 years; (4) Known history of severe allergic reaction to anti-PD-1 monoclonal antibodies; (5) Active infection requiring systemic therapy; (6) Evidence of gastrointestinal bleeding tendency; (7) Arterial or venous thrombotic events within the past year; (8) History of drug abuse with inability to discontinue use, or presence of psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two-year recurrence-free survival rate;Overall survival;Two-year overall survival rate;Adverse events;Serious adverse events; | — |
Countries
China
Contacts
Public ContactXiang Bangde, Li Jianxu
Guangxi Medical University Cancer Hospital
Outcome results
None listed