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NCT Number: NCT06346808

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location contact

Zhong Wu, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years and age ≤75 years. ECOG score 0-1. Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

Adequate bone marrow and organ function:

Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.

Signed informed consent. Ability to comply with the study protocol and follow-up.

Exclusion criteria

  • Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
  • Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
  • Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
  • Serious uncontrolled medical conditions that may interfere with the subject's ability to receive treatment as specified in the protocol, including, but not limited to, positive HIV test, active tuberculosis, and DNA copy number of HBV >103/ml;
  • Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
  • Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
  • Pregnant or lactating women;
  • Those who may be allergic to the study drug or any of its excipients;
  • Preoperative ultrasound evaluation of patients with small tumor size, location near or behind major blood vessels, and various other factors that may result in a low success rate of intra-tumoral viral injection under ultrasound and a high rate of post-injection complications;
  • Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
  • Any uncertainty that affects patient safety or compliance.

Treatment and study plan

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Drug

Oncolytic virus,Camrelizumab ,AG(Gemcitabine +Capecitabine )

Primary outcomes

  1. Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

    Time frame: through study completion, an average of 1 year

    Defined by treatment-related adverse events as assessed by CTCAE v4.0

Secondary outcomes

  1. R0 resection rate

    Time frame: 6 months

    defined as complete resection without any macroscopic or microscopic evidence of lesion at the lateral and deep tissue margins

  2. ORR

    Time frame: 6 months

    The incidence of CR (complete remission) and PR (partial remission)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhong Wu, MD

CONTACT

[email protected]

028-85422851

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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