Pancreatic CancerPhase 1/2NCT06758544
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer
A Phase 1/2 study testing Oncolytic virus VRT106 and Chemotherapy in people with Pancreatic Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Oncolytic virus VRT106 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 30 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
About this study
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.
Read the 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).
- Conditions
- Pancreatic Cancer
- Being tested
- Oncolytic virus VRT106, Chemotherapy
- Keywords
- Resectable pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncolytic virus VRT106Drug
VRT106, IV
ChemotherapyDrug
21 days/cycle, administered up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| VRT106 combination with chemotherapy | Experimental | VRT106 combination with chemotherapy Receives: Drug: Oncolytic virus VRT106; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence rate of TRAE（Treatment-Related Adverse Event）
Measured: About 3 years
Secondary outcomes (1)
Disease-free survival rate
Disease-free survival rates at 6, 12, 18, and 24 months
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start17 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758544
- Sponsor's protocol ID
- VRT106-C05
- Status last verified
- Aug 2025
- First submitted
- 2 Jan 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06758544
- Acronym / sponsor ID
- VRT106-C05
- Conditions
- Pancreatic Cancer
- Keywords
- Resectable pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRT106 combination with chemotherapy | Experimental | Drug: Oncolytic virus VRT106, Drug: ChemotherapyVRT106 combination with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncolytic virus VRT106VRT106, IV | Drug | VRT106 combination with chemotherapy |
| Chemotherapy21 days/cycle, administered up to 6 cycles | Drug | VRT106 combination with chemotherapy |
Primary outcome
Safety and tolerability
Time frame: About 3 years
Incidence rate of TRAE（Treatment-Related Adverse Event）
1 secondary outcome
Disease-free survival rate
Time frame: About 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oncolytic virus VRT106 and Chemotherapy in people with Pancreatic Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen RF Prof. (020-83525210, chenrf63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: About 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.