Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSir Run Run Shaw Hospital

About this trial

Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) 18~75 years old (including boundary values).

(2) The first diagnosis confirmed by histology or cytology is HCC.

(3) Barcelona Clinical Liver Cancer (BCLC) stage A-B has undergone curative resection of the tumor, with no extrahepatic metastasis or adjacent organ invasion before surgery.

(4) Must meet at least one of the high-risk recurrence risk criteria (as follows): Characteristics of high-risk recurrent liver cancer after surgery: preoperative single lesion>5cm; MVI positive; Preoperative presence of sub lesions; Intraoperative margin<1cm.

Disqualifiers

(1) The pathological diagnosis is non hepatocellular carcinoma.

(2) Within one month after surgery, there may be intrahepatic or extrahepatic recurrence.

(3) Previously received anti-tumor treatment plans such as chemotherapy, radiotherapy, radiofrequency ablation, interventional therapy, targeted therapy, and immunotherapy for liver cancer (excluding previous non tumor related surgeries and diagnostic biopsies).

(4) The viral load is limited to hepatitis B virus (HBV) DNA>2500 copies/ml, hepatitis C virus (HCV) RNA>1000, and no treatment has been received.

Trial design

Design model

Single group

Treatments tested in this trial

Tislelizumab: 200mg, intravenous infusion, Q3W
Drug
Postoperative adjuvant therapy (maximum of 8 cycles, each cycle lasting 21 days): \- Tislelizumab: 200 mg, intravenous infusion, Q3W. Based on previous preclinical and clinical studies on circadian rhythms and adaptive immune responses, blood samples will be collected from patients at 05:00-07:00, 11:00-13:00, 17:00-19:00, and 23:00-01:00 (every 6 hours) to analyze the subset classification of peripheral blood lymphocytes. This will help map the immune circadian rhythm and determine the optimal injection time (which will then be used as the dosing time).

Treatment groups

33 Participants

are divided into 1 treatment group

Group A: Cohort 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

2-year recurrence-free survival (RFS) rate

Time frame

2year

Secondary outcomes

recurrence-free survival (RFS)

Duration from surgery to the first recorded HCC recurrence or all-cause death (whichever occurs first)

Time frame

From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Time to recurrence (TTR)

Defined as the time from enrollment to the first recorded disease recurrence assessed by the investigator,including the occurrence of local, regional, or metastatic HCC.

Time frame

From date of randomization until the date of first documented progression, assessed up to 36 months

Overall survival (OS)

Time from surgery to date of death, irrespective of cause.

Time frame

From date of surgery until the date of death from any cause, whichever came first, assessed up to 36 months

1-year recurrence-free survival (RFS) rate

Time frame

1 year

Other outcomes

The incidence, severity, and correlation with the investigational product of adverse events (all adverse events, treatment emergent adverse events, serious adverse event)

Time frame

2year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Run Run Shaw Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now