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PIN in Combination With Sintilimab in Previously Treated pMMR/MSS CRC With Hepatic Metastases
Sponsor: Chinese PLA General Hospital
Summary
In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with anti-programmed cell death -1 (anti-PD1) antibody therapeutic regimen (sintilimab) will be evaluated in patients with advanced proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC) with hepatic metastases . A total of 25 to 30 patients are planned to be enrolled and receive PIN plus sintilimab combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.
Official title: Treatment of Pyroptosis-inducible Newcasstle Disease Oncolytic Virus (PIN) Plus Sintilimab (Anti-PD1 Antibody) for Patients With Advanced pMMR/ MSS Colorectal Cancer With Hepatic Metastases:an Open-Label, Randomized,Phase I Study.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-03-01
Completion Date
2031-03-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
PIN+sintilimab
1.Initial treatment phase: PIN injection frequency: day 0 and day 3, per 3 weeks for 8 cycles; PIN injection dosage: Cycle1: 4e9 or 8e9 viral particles based on the number of injectable lesions, their longest diameter, and the tumor volume capacity . Cycle 2\~8: 4e9 or 8e9 viral particles based on the tumor volume's capacity.Sintilimab: day -3, per 3 weeks for 8 cycles; 2.Maintenance treatment phase: No injection lesion: Sintilimab: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. Have injection lesion: PIN: 4e9 or 8e9 viral particles based on the tumor volume's capacity, per 6 weeks (within first 24 weeks), then per 8 weeks till 2 years unless unavailability of injection lesion, PD or serious intolerable AEs.Sintilimab: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. 3.Salvage treatment phase: Dosage and frequency of administration refer to the initial treatment phase and maintenance treatment phase.
Locations (1)
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China