Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon… (NCT06580574) | Clinical Trial Compass
RecruitingPhase 2
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
China34 participantsStarted 2024-09-13
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* dMMR confirmed by immunohistochemistry or MSI-H confirmed by PCR and NGS. If MSI status and MMR status were not consistent, whether to enroll this patient should be determine by investigators. Patients with MMR heterogeneity in tumors could not be included.
* Patients who are about to receive or are receiving 24 weeks of PD1/PDL1 antibody monothearpy and have not had the first efficacy assessment.
* Archived tumor tissue samples or freshly obtained tumor tissue samples are available.
* Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.
* Subjects have the ability and willingness to comply with the study protocol's visits, treatment plan, laboratory tests, and other study-related procedures.
* For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib. subjects should have good organ function within t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on 'organ preservation' — can you explain what that means specifically for my situation, and whether avoiding surgery is a realistic and safe goal given where my cancer stands right now?
2Since this is a Phase 2 trial, what do we actually know so far about how well immune checkpoint inhibitors work for dMMR/MSI-H gastric or colon cancers, and what are the biggest unknowns or risks I should understand before considering this?
3My tumor has been identified as dMMR or MSI-H — does that mean I'm the kind of patient this trial was designed for, and are there any other features of my cancer that might make me a better or worse fit?
4If I were to join this trial and the immune checkpoint inhibitor doesn't preserve the organ as hoped, would I still be able to have surgery or other standard treatments afterward, or could participating limit my options down the road?
5How does joining this trial compare to just going ahead with standard surgery now — what would I be giving up or gaining in terms of what's already proven to work versus what this study is still trying to find out?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Organ preservation rate
Timeframe: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, 12 weeks after Sintilimab, IBI310 and Lenvatinib, and 24 weeks after Sintilimab, IBI310 and Lenvatinib