A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oncolytic virus VRT106, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.
Detailed description
This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.
The study is planned to enroll 18 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).
Interventions
- Drug Oncolytic virus VRT106
VRT106, IV - Drug Chemotherapy
21 days/cycle, administered up to 6 cycles
Primary outcome measures
- Safety and tolerability [Time frame: About 3 years]
Secondary outcome measures (1)
- Disease-free survival rate [Time frame: About 2 years]
Eligibility criteria
Inclusion criteria
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- Have a clinical diagnosis of pancreatic cancer.
- An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Expected survival time of≥6 months.
- No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
Exclusion criteria
- Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
- Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Immunocompromised patients.
- Known alcohol or drug dependency.
- Women who are pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT06758544 · VRT106-C05