Dalpiciclib plus camrelizumab for advanced liver cancer after prior immunotherapy
A Prospective, Randomized, Two-Cohort, Exploratory Clinical Study of Dalpiciclib Combined With Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors
This trial will test whether combining dalpiciclib with camrelizumab can control tumors in people with unresectable hepatocellular carcinoma whose cancer progressed after prior immune checkpoint inhibitor treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | camrelizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07238881 on ClinicalTrials.gov |
What this trial studies
This is an exploratory phase 2 interventional trial giving patients a CDK4/6 inhibitor (dalpiciclib) together with the anti–PD‑1 antibody camrelizumab to characterize safety and antitumor activity. Eligible participants have unresectable hepatocellular carcinoma, measurable disease, prior progression on immune checkpoint inhibitors, ECOG performance status 0–1, and Child‑Pugh class A liver function. The trial will monitor imaging-based tumor responses, safety labs, and adverse events while patients receive the combination regimen. Conducted at Sun Yat‑sen University Cancer Center, the study aims to generate preliminary efficacy signals to inform larger studies.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable, measurable hepatocellular carcinoma who progressed on prior ICI therapy, have good performance status (ECOG 0–1), and preserved liver function (Child‑Pugh A).
Not a fit: Patients with decompensated liver disease (Child‑Pugh B or C), poor performance status (ECOG ≥2), significant organ dysfunction, or those eligible for curative local therapy are unlikely to be eligible or to benefit from this regimen.
Why it matters
Potential benefit: If successful, the combination could provide a new second-line treatment option that improves response rates or disease control for patients with advanced HCC after prior immunotherapy.
How similar studies have performed: Preclinical data suggest synergy between CDK4/6 inhibitors and PD‑1 blockade, but the specific combination of dalpiciclib and camrelizumab has not previously been tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * Barcelona clinic liver cancer-stage C * Patients who have previously received first-line treatment with ICI treatments (including PD-1/PD-L1/CTLA-4) and who have shown tumor progression as confirmed by imaging studies. * Eastern Cooperative Oncology Group performance status of 0 to 1 * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * The following laboratory parameters: Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.