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Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

ConditionsPancreatic CancerAdjuvant Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and age ≤75 years.

ECOG score 0-1.

Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.

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

Disqualifiers

Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.

The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).

Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.

HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.

Trial design

Design model

Single group

Treatments tested in this trial

  • Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

    Drug

    Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Neoantigen Vaccine Plus Anti-PD1 and ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

18-month RFS

defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.

Time frame
through study completion, an average of 2 year
2

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

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

Time frame
3 months after the last administration of neoantigen vaccine

Secondary outcomes

1

18-month OS

defined OS from the date of surgery to the date of death.

Time frame
through study completion, an average of 3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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