Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC

Condition(s) studied

Investigational drug(s) / intervention(s)

Oxaliplatin: Oxaliplatin 130mg/m2 for inducing chemotherapy in Day 1 every 3 weeks and repeat for two cycles.

Capecitabine: Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy in Day 1 to Day 14 every 3 weeks and repeat for 2 cycles.

Anti-PD-1 monoclonal antibody: Anti-PD1 antibody 200mg/m2 in Day 1 after oxaliplatin Chemotherapy. Repeat every 3 weeks for 2 cycles.

Sitagliptin (DPP4 inhibitor): Oral sitagliptin twice daily combined with oxaliplatin chemotherapy in Day 1 to Day 14 every 3 weeks and repeat for 2 cycles. In the phase Ib study, sitagliptin set at three dose groups: 100 mg/day, 200 mg/day, and 400 mg/day, and the primary endpoint of Ib study is to determine the DLT and recommended phase II dose (RP2D). The appropriate dose level of sitagliptin will be set based on the result of Ib study.

Study summary

This is an open-label, multicenter, phase Ib/II combined trial of sitagliptin, XELOX chemotherapy regimen, and PD-1 monoclonal antibody in the treatment of proficient mismatch repair locally advanced colorectal cancer.

Eligibility

Primary outcome measure(s)

• Adverse events (AEs) — From date of first chemotherapy until the date of patients were discharged from hospital after receiving radical surgery, up to 20 weeks
  for Ib study
• Dose limiting toxicities (DLTs) — The DLT observation period is from the day1 of the first cycle(C1D1) to the start of the day1 of the second cycle(C2D1) dosing, each cycle is 21 days.
  for Ib study
• Proportion of patients achieving tumor regression grade 0/1 (TRG 0/1) — 1 day of postoperative pathological examination.
  for II study

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

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