Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University

About this trial

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

Eligibility criteria

Qualifiers

Subjects are able to comprehend the informed consent form, and voluntarily sign the informed consent form.

Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.

Histologically confirmed gastric cancer or colon cancer, without distant metastasis based on CR or MR.

ECOG performance status of 0-2.

Disqualifiers

Distant metastasis;

Previous treatment including CTLA4 blockade;

Subjects with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.

Subjects with active autoimmune diseases requiring systemic treatment before the start of the study or those considered at risk of recurrence or planned treatment for autoimmune diseases as judged by the investigator. Except for these conditions: a) skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); b) hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; c) type 1 diabetes requiring stable doses of insulin replacement therapy; d) childhood asthma fully resolved with no need for intervention in adulthood; e) the investigator judges that the disease will not relapse without external triggering factors.

Trial design

Treatments tested in this trial

  • PD1/PDL1 antibody monotherapy, up to 24 weeks
  • Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks
  • Radical surgery

Treatment groups

34 Participants
are divided into 2 treatment groups

Locations

1
Beijing Cancer Hospital100142, BeijingBeijing Municipality, China

Sponsors and collaborators

Peking University

Lead sponsor