OncoMatch/Clinical Trials/NCT07331883
Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma (CLEAR-2)
Is NCT07331883 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab plus bevacizumab biosimilar for hepatocellular carcinoma (hcc).
Treatment: Sintilimab plus bevacizumab biosimilar — Primary liver cancer-particularly hepatocellular carcinoma (HCC)-remains a major health burden in China, characterized by high incidence and mortality rates and poor 5-year survival. Spontaneous rupture of HCC (SRHCC), although a relatively uncommon complication, is associated with extremely high mortality and marked geographic variation, with disproportionately higher incidence and rupture-related deaths reported in Asian populations. For patients with preserved liver function and resectable tumors, hepatic resection can offer favorable long-term survival and even a potential cure. However, despite surgical removal, the risk of postoperative recurrence is substantially increased, and long-term outcomes remain unsatisfactory. Currently, there is no validated adjuvant therapy to reduce recurrence or improve survival after resection. In recent years, immune checkpoint inhibitors (ICIs) in combination with anti-angiogenic agents have demonstrated synergistic antitumor activity and manageable safety in advanced HCC. Notably, studies of sintilimab plus a bevacizumab biosimilar have shown significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Moreover, emerging evidence in the adjuvant and perioperative settings suggests that PD-1 blockade may delay recurrence in high-risk patients, such as those with microvascular invasion. Based on the high postoperative recurrence rate in SRHCC patients and the existing therapeutic gap, along with established evidence of the efficacy of immune checkpoint inhibitors combined with antiangiogenic therapy in advanced HCC, conducting a prospective Phase II single-arm study of adjuvant therapy with sintilimab plus the bevacizumab biosimilar holds significant clinical and scientific value. This study aims to evaluate the tolerability of this combination regimen in postoperative SRHCC patients at high risk of recurrence. It is expected to provide a more effective treatment option for patients diagnosed with spontaneously ruptured hepatocellular carcinoma, improve their prognosis, and offer scientific evidence for future treatment strategies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage CNLC STAGE I, CNLC STAGE II (CNLC)
CNLC Stage I-II
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative surgical resection — adjuvant
Having undergone curative surgical resection, with intraoperative irrigation using ≥5000 mL of distilled water or normal saline, confirmed negative surgical margins on postoperative pathology, and achieving a complete response (CR) confirmed by imaging within 4-8 weeks after surgery.
Cannot have received: systemic antitumor therapy
Exception: preoperative TAE for hemostasis is allowed
Prior systemic antitumor therapy, including targeted therapy, immunotherapy, investigational drugs, or local therapies such as TACE (preoperative TAE for hemostasis is allowed). Patients who received adjuvant TACE after resection are also excluded.
Cannot have received: intraoperative intraperitoneal lavage with chemotherapeutic agents
Intraoperative intraperitoneal lavage with chemotherapeutic agents [excluded]
Cannot have received: adjuvant TACE after resection
Patients who received adjuvant TACE after resection are also excluded.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5 × ULN, or creatinine clearance >50 mL/min
Liver function
Child-Pugh A (score ≤6); Serum albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT and AST ≤3 × ULN
Cardiac function
NYHA classification <II; LVEF ≥50%; QTc interval ≤450 ms (males) or ≤470 ms (females)
Child-Pugh A (score ≤6); Hematological: Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Hemoglobin ≥90 g/L. Serum albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT and AST ≤3 × ULN; Serum creatinine ≤1.5 × ULN, or creatinine clearance >50 mL/min. NYHA classification <II; LVEF ≥50%; QTc interval ≤450 ms (males) or ≤470 ms (females)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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