Actively Recruiting
Neoadjuvant Triple Therapy for Resectable HCC
Led by Fujian Provincial Hospital · Updated on 2024-10-15
20
Participants Needed
6
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).
CONDITIONS
Official Title
Neoadjuvant Triple Therapy for Resectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to join the study and sign informed consent.
- Male or female aged between 18 and 75 years.
- Child-Pugh class A liver function.
- Indocyanine green 15-minute retention rate (ICGR-15) less than 15%.
- ECOG performance status of 0 or 1.
- Diagnosed with hepatocellular carcinoma according to 2022 guidelines.
- BCLC stage A or B with a single tumor larger than 5 cm or multiple tumors, deemed surgically removable.
- At least one measurable lesion (long diameter 10 mm or more) on CT/MRI without prior local treatment.
- Blood counts: neutrophils ≥ 1.5 × 10^9/L, hemoglobin ≥ 8.5 g/L, platelets ≥ 75 × 10^9/L.
- No serious heart, lung, or kidney problems; creatinine clearance rate over 40 mL/min.
- Women of childbearing potential must use contraception during and 6 months after treatment, have a negative pregnancy test within 7 days before joining, and not be breastfeeding.
- Men must agree to use contraception during the study and for 6 months after.
You will not qualify if you...
- Tumor rupture with bleeding or suspected abdominal metastasis.
- Prior antitumor treatments including surgery, targeted drugs, immunotherapy, chemotherapy, radiotherapy, or Huaier granules.
- Allergy to lenvatinib, cadonilimab, or their components.
- Active or recurrent autoimmune diseases, except stable hypothyroidism or type 1 diabetes.
- History of immunodeficiency or recent use of immunosuppressive drugs or corticosteroids.
- Known bleeding or clotting disorders or recent use of full-dose anticoagulants or thrombolytics.
- Severe infection within 4 weeks before treatment or signs of active lung inflammation.
- Protein in urine of 1+ or higher; if confirmed 24-hour urine protein ≥ 1 g.
- Other cancers within 5 years except certain cured skin, cervical, or thyroid cancers.
- Psychiatric disorders or history of substance or alcohol abuse.
- Pregnant or breastfeeding women.
- Significant surgical contraindications or any other conditions judged unsuitable by investigators.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Fujian provincial hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Not Yet Recruiting
3
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
Not Yet Recruiting
4
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China, 361005
Not Yet Recruiting
5
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361021
Not Yet Recruiting
6
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China, 363099
Not Yet Recruiting
Research Team
M
Mao-Lin Yan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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