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New treatment option for Gastric Cancer
Official title Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
ClinicalTrials.gov ID: NCT06580574
What this study is testing
What is PD1/PDL1 antibody monotherapy, up to 24 weeks?
PD1/PDL1 antibody monotherapy, up to 24 weeks is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people are able to comprehend the informed consent form, and voluntarily sign the informed consent form.
- people 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...
You likely can't join if
- Distant metastasis;
- Previous treatment including CTLA4 blockade;
- people with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.
- people with active autoimmune diseases requiring systemic treatment before the start of the study or those considered at risk of recurrence or...
- people with a history of other malignant tumors within 5 years, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive...
- people with uncontrolled comorbidities, including but not limited to: a) active HBV or HCV infection; b) people who are HBsAg positive and/or HCV...
See the full eligibility criteria
- people are able to comprehend the informed consent form, and voluntarily sign the informed consent form.
- people 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...
- Patients who are about to receive or are receiving 24 weeks of PD1/PDL1 antibody monothearpy and have not had the first how well it works assessment.
- Archived tumor tissue samples or freshly obtained tumor tissue samples are available.
- Female people of childbearing potential or male people 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...
- people 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. people should have good organ function within the first 7 days of initial dosing: HGB ≥ 80g/L, NEU ≥ 1.0\ 10\^9/L, PLT ≥ 75\...
- Distant metastasis;
- Previous treatment including CTLA4 blockade;
- people with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.
- people 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...
- people with a history of other malignant tumors within 5 years, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder carcinoma, localized low-risk prostate cancer (defined as stage...
- people with uncontrolled comorbidities, including but not limited to: a) active HBV or HCV infection; b) people who are HBsAg positive and/or HCV antibody positive during screening must undergo HBV DNA and/or HCV RNA...
- History of allogeneic bone marrow or organ transplantation.
- Previous history of allergic reactions, hypersensitivity reactions, or intolerance to antibody drugs (e.g., severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia).
- Pregnant and/or lactating females.
- For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib: a) people with a history of gastrointestinal perforation or fistula within 6 months before the first dose. If the perforation or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.