XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

Sponsor
Wu Wenming
Study ID
NCT06353646
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • XH001 — BIOLOGICAL
    XH001 will be administered 12 weeks post-tumor resection (+/- 2 weeks)
  • Ipilimumab Injection — DRUG
    Ipilimumab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
  • Sintilimab injection — DRUG
    Sintilimab will be administered 12 weeks post-tumor resection (+/- 2 weeks)
  • Chemotherapy — DRUG
    gemcitabine + capecitabine

Study Details

This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.

Key Dates

Start date
Mar 12, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    XH001;Ipilimumab Injection;Chemotherapy
  • Experimental: Arm B
    XH001;Sintilimab Injection;Chemotherapy

Primary Outcome Measure

DFS [ Time Frame: From operation up to 36 months ]

Central Contacts

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