Actively Recruiting
Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment
Led by Sun Yat-sen University · Updated on 2025-11-20
30
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
While immune-based therapies (including targeted-immune or dual-immune regimens) have become first-line standard for advanced hepatocellular carcinoma (HCC), there is a lack of high-level evidence to guide second-line treatment after progression on immune checkpoint inhibitors (ICIs). Preclinical studies suggest synergistic antitumor activity between CDK4/6 inhibitors and PD-1/PD-L1 blockade. However, no clinical studies have yet evaluated the combination of dalpiciclib and camrelizumab in this setting. To address this unmet need and explore novel second-line strategies for advanced HCC, we plan to conduct an exploratory clinical trial investigating the efficacy and safety of dalpiciclib plus camrelizumab in patients with unresectable HCC previously treated with ICIs.
CONDITIONS
Official Title
Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma (HCC) based on European Association for the Study of the Liver (EASL) criteria
- At least one tumor lesion measurable by EASL standards
- Barcelona clinic liver cancer stage C
- Previous first-line treatment with immune checkpoint inhibitors and confirmed tumor progression
- Eastern Cooperative Oncology Group performance status of 0 to 1
- No cirrhosis or cirrhosis limited to Child-Pugh class A
- Not suitable for surgical resection, local ablative therapy, or other curative treatments
- Laboratory values meeting specified limits: hemoglobin 8.5 g/dL, total bilirubin �a430 mmol/L, serum albumin �b930 g/L, AST and ALT �a45 times upper limit of normal, serum creatinine �a41.5 times upper limit of normal, INR �a41.5 or normal PT/APTT, absolute neutrophil count >1,500/mm3
- Ability to understand the protocol and provide written informed consent
You will not qualify if you...
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known history of HIV infection
- History of organ transplantation
- Known or suspected allergy to study drugs or related agents
- Cardiac ventricular arrhythmias requiring treatment
- Evidence of bleeding disorders
- Significant gastrointestinal bleeding within 30 days before study entry
- Known central nervous system tumors including brain metastases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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