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

NCT06344156 | Recruiting Phase 1

• 1 other identifier: CHANT-231
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer; Adjuvant Therapy

Keywords

Pancreatic Cancer; Neoantigen; Adjuvant therapy; Safety; Clinical efficacy

Outcome Measures

Primary Outcomes (2)

• 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.

  through study completion, an average of 2 year

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

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

  3 months after the last administration of neoantigen vaccine

Secondary Outcomes (1)

• 18-month OS

  through study completion, an average of 3 year

Study Arms (1)

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

EXPERIMENTAL

(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110)

Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Interventions

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy DRUG

Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
• Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
• Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
• Pregnant or lactating women.
• Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination.
• Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
• Those who may be allergic to the investigational product or any of its excipients.
• Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
• Significant weight loss (≥10%) within 6 weeks prior to enrollment.
• Any uncertain factors that may affect patient safety or compliance.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• zhong Wu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhong Wu, MD

CONTACT

028-85422851; wuzhong5555@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)