Actively Recruiting
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 for High-risk Recurrent HCC
Led by Sun Yat-sen University · Updated on 2025-09-29
39
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma (HCC), with a 5-year overall survival rate of 60-80% post-surgery. Therefore, guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC (CNLC stages IA-IIA or BCLC stages A/B) patients with well liver reserve function. However, the high postoperative recurrence rate is the main factor limiting long-term survival in HCC patients, with literature reporting recurrence rates exceeding 70%. Among these, half of the patients experience recurrence within two years post-surgery, imposing a heavy burden on patients' physical and mental health as well as on societal medical resources. Adopting effective treatment to improve surgical curability and reduce postoperative recurrence rates is one of the current research hotspots. Recent studies from the investigators' center indicate that hepatic arterial infusion chemotherapy (HAIC) and immunotherapy can provide definite efficacy for patients with advanced HCC, extending their survival time. Mechanistically, chemotherapy and immunotherapy have synergistic effects: tumor cell necrosis induced by chemotherapy can promote immune activation, while cytokines and neutralizing antibodies secreted by immune cells can enhance the toxicity of chemotherapeutic drugs. Therefore, this study aims to conduct a prospective, single-arm, phase II clinical study, targeting HCC patients with high-risk recurrence factors, to evaluate whether neoadjuvant HAIC combined with a PD-1 monoclonal antibody (Tislelizumab) followed by adjuvant Tislelizumab post-surgery can reduce postoperative recurrence rates in HCC patients. The primary endpoint is the 1-year recurrence-free survival (RFS) rate post-surgery, while secondary endpoints include the objective response rate (ORR) of neoadjuvant therapy, the incidence of perioperative complications, the incidence of treatment-related adverse events, overall survival (OS) time, pathological complete response (pCR) rate of neoadjuvant therapy, and major pathological response (MPR) of neoadjuvant therapy. The investigators aim to comprehensively assess the efficacy and safety of neoadjuvant HAIC plus PD-1 and adjuvant PD-1 in the perioperative treatment of HCC.
CONDITIONS
Official Title
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 for High-risk Recurrent HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and untreated hepatocellular carcinoma
- Tumor stage beyond Milan criteria (single tumor >5 cm, or 2-3 tumors with largest >3 cm), resectable CNLC stage Ib/IIa
- No tumor thrombus, distant or lymph node metastasis
- Normal liver volume ≥ 700 cc, estimated residual liver volume >40% after surgery
- Karnofsky performance score ≥ 90
- Liver function Child-Pugh class A
- Estimated survival time more than 6 months
- Adequate organ function: white blood cells ≥ 4.0×10^9/l, neutrophils ≥ 1.5×10^9/l, platelets ≥ 80.0×10^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5 × ULN; ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min
- Ability to understand and voluntarily sign informed consent and comply with study requirements
You will not qualify if you...
- Severe impairment of heart, lung, kidney functions or active infections except viral hepatitis
- Contraindications to surgery or immunotherapy
- History of other malignant tumors
- Immunological diseases or conditions needing long-term steroids
- Known or suspected allergy to study drug or related medications
- History of organ transplantation
- Pregnant or breastfeeding women
- Factors affecting enrollment or assessment outcomes
- Refusal to follow-up or sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yaojun Zhang, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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