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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma (CLEAR-2)
ClinicalTrials.gov ID: NCT07331883
What this study is testing
What is Sintilimab plus bevacizumab biosimilar?
Sintilimab plus bevacizumab biosimilar is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any...
- Age ≥ 18 years and ≤ 75 years; both female and male
- Spontaneous tumor rupture with hemorrhage confirmed by imaging prior to or during surgery, with a postoperative pathological diagnosis of...
- CNLC Stage I-II.
- Having undergone curative surgical resection, with intraoperative irrigation using ≥5000 mL of distilled water or normal saline, confirmed negative...
You likely can't join if
- Pathological diagnosis other than hepatocellular carcinoma, including cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma.
- Intraoperative intraperitoneal lavage with chemotherapeutic agents
- Child-Pugh class B or C
- ECOG PS \> 1
- Postoperative imaging confirming the presence of extrahepatic metastasis, residual disease, or recurrence.
- Prior systemic antitumor therapy, including targeted therapy, immunotherapy, investigational drugs, or local therapies such as TACE (preoperative TAE...
See the full eligibility criteria
Who can join
- Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.
- Age ≥ 18 years and ≤ 75 years; both female and male
- Spontaneous tumor rupture with hemorrhage confirmed by imaging prior to or during surgery, with a postoperative pathological diagnosis of hepatocellular carcinoma (HCC). a) For cases where tumor rupture is an incidental...
- CNLC Stage I-II.
- 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...
- ECOG PS 0-1
- Child-Pugh A (score ≤6).
- Life expectancy ≥12 months
- Laboratory test results obtained within 3 days prior to the first dose must meet the following criteria:
- Hematological:(Except for hemoglobin, the patient must not have received a blood transfusion, granulocyte colony-stimulating factor [G-CSF], or hematopoietic agents within 2 weeks prior to screening.) i. Absolute...
- Serum biochemistry: i. Serum albumin ≥30 g/L; ii. Total bilirubin ≤1.5 × ULN; iii. ALT and AST ≤3 × ULN; iv. Serum creatinine ≤1.5 × ULN, or creatinine clearance \>50 mL/min.
- International normalized ratio (INR) ≤1.2 or prothrombin time (PT) ≤2 seconds above the upper limit of normal.
- Urinalysis:Urine protein \<2+.(If urine protein is ≥2+, a 24-hour urine protein test may be performed; patients may be enrolled if 24-hour urine protein \<1.0 g.)
- For patients with HBV infection (i.e., HBsAg-positive), HBV DNA must be tested. HBV DNA levels must be \<2000 IU/mL (or \<10⁴ copies/mL if the study site reports results in copies/mL). Patients with HBV DNA ≥2000 IU/mL...
- Female patients of childbearing potential must have a negative β-hCG pregnancy test prior to the first dose. Female patients of childbearing potential and male patients with partners of childbearing potential must agree...
What rules you out
- Pathological diagnosis other than hepatocellular carcinoma, including cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma.
- Intraoperative intraperitoneal lavage with chemotherapeutic agents
- Child-Pugh class B or C
- ECOG PS \> 1
- Postoperative imaging confirming the presence of extrahepatic metastasis, residual disease, or recurrence.
- 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...
- Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage, or a Child-Pugh ascites score \>2 (the presence of minimal ascites on imaging only, without associated symptoms, is...
- Current interstitial lung disease (ILD), or a history of ILD requiring glucocorticoid treatment, or other conditions that might interfere with the diagnosis or management of immune-related pulmonary toxicity, including...
- Presence of an active autoimmune disease, or a history of autoimmune disease with potential for recurrence [including, but not limited to, autoimmune hepatitis, pneumonitis, uveitis, colitis, hypophysitis, vasculitis...
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at doses \>10 mg/day prednisone or equivalent) within 2 weeks prior to initiation of study treatment. Inhaled or topical...
- History of gastrointestinal bleeding within 6 months prior to treatment, or definite predisposition to gastrointestinal bleeding, such as high-risk or severe esophageal/gastric varices, active peptic ulcer disease, or...
- Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendency, such as hemophilia, coagulopathy, thrombocytopenia, etc. Current therapeutic use of full-dose oral or injectable anticoagulants...
- History of thrombotic or embolic events within 6 months prior to treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
- Poorly controlled or significant cardiac disease, including: (1) Cardiac dysfunction ≥ Grade II per New York Heart Association (NYHA) classification, or left ventricular ejection fraction (LVEF) \ 450 ms (males) or...
- Hypertension that is not adequately controlled with antihypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, based on the average of ≥2 readings). History of hypertensive crisis or hypertensive...
- Major vascular disease within 6 months prior to treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).
- Severe, non-healing, or dehisced wounds, active ulcers, or unhealed bone fractures.
- Inability to swallow tablets, malabsorption syndrome, or any condition compromising gastrointestinal absorption.
- Severe infection within 4 weeks prior to treatment, including, but not limited to, hospitalization for infection, bacteremia, or severe pneumonic complications. Therapeutic antibiotics (oral or intravenous) within 14...
- Known congenital or acquired immunodeficiency (e.g., HIV infection).
- Administration of live attenuated vaccines within 28 days prior to treatment, or anticipation of need for such vaccines during the study period.
- Any other condition that, in the investigator's judgment, may affect the interpretation of results, compromise patient safety, or lead to premature study termination. This includes alcohol or substance abuse, other...
The study team makes the final eligibility decision.
Where it's taking place
- Sanming, Fujian, China
- Changchun, Jilin, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sanming, Fujian, China; Changchun, Jilin, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.