Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer

Sponsor
Ruijin Hospital
Study ID
NCT07745790
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multimodal Thermal Therapy (MTT) System — DEVICE
    The MTT system is a medical device that performs sequential ablation therapy. Treatment consists of initial cryoablation followed immediately by radiofrequency ablation (RFA) to achieve a synergistic thermal effect against the tumor.
  • KRAS G12V mRNA Vaccine — BIOLOGICAL
    Administered via intramuscular injection at a dose of 1 mg. The first dose will be given 1 to 3 days after Multimodal Thermal Therapy (MTT). Subsequent doses will be administered every 3 weeks (Q3W) according to the study dosing schedule and clinical discretion.
  • Sintilimab — DRUG
    Administered via intravenous infusion at a dose of 200 mg on Day 1 (d1). Treatment will begin on 7 days after MTT and will be repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity.
  • S-1 — DRUG
    Only participants aged \<80 years will receive oral S-1. Treatment starts on Day 7 after MTT at a dose of 40-60 mg twice daily (bid) on Days 1 to 14 (d1-14) of each cycle. Cycles are repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity.

Study Details

This is a single-arm, single-center, exploratory clinical study. A total of 20 participants with metastatic pancreatic ductal adenocarcinoma (with liver or lung metastasis) who have experienced disease progression after or are intolerant to standard first-line chemotherapy (based on the AG regimen \[Albumin-bound Paclitaxel plus Gemcitabine\]) will be enrolled.The study aims to evaluate the safety, efficacy, and underlying immunological mechanisms of Multimodal Thermal Therapy (MTT) combined with a KRAS G12V mRNA vaccine, S-1, and Sintilimab.

Key Dates

First listed
Aug 4, 2026
Start date
Jul 13, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    MTT + KRAS G12V mRNA Vaccine + Sintilimab ± S-1 Participants will receive Multimodal Thermal Therapy (MTT) combined with KRAS G12V mRNA vaccine and sintilimab. In addition, oral S-1 (tegafur/gimeracil/oteracil) will be administered to participants aged \<80 years. Participants aged ≥80 years will receive MTT + KRAS G12V mRNA vaccine + sintilimab without S-1.

Primary Outcome Measure

Incidence and Severity of Adverse Events (CTCAE v6.0) [ Time Frame: From the start of treatment up to 90 days after the last dose (or end of treatment). ]

Central Contacts

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