A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced 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: from 18 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 →
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Overview
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.
Detailed description
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.
The study is planned to enroll 10 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
Primary outcome measures
- Safety and tolerability [Time frame: About 3 years]
Secondary outcome measures (1)
- Overall survival rate [Time frame: About 3 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≥18 years of age, inclusive, at the Screening Visit.
- Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology.
- No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer.
- Have at least one measurable lesion according to RECIST v1.1 criteria.
- An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Expected survival time of≥3 months.
- No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
Exclusion criteria
- Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ.
- Previous treatment with other oncolytic viruses.
- 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
- Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT06866977 · VRT106-C04