Actively Recruiting
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
Led by Peking University · Updated on 2024-08-30
38
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- 18 years or older at the time of consent, any gender
- Histologically confirmed gastric or colon cancer without distant metastasis
- ECOG performance status of 0 to 2
- Confirmed dMMR by immunohistochemistry or MSI-H by PCR and NGS
- Receiving or about to receive 24 weeks of PD1/PDL1 antibody monotherapy without prior efficacy assessment
- Available archived or fresh tumor tissue samples
- Use of effective contraception from 7 days before first dose to 120 days after last dose for those of childbearing potential
- Negative serum pregnancy test within 7 days before first dose for females of childbearing potential
- Ability and willingness to comply with study visits, treatment, and procedures
- For combination treatment candidates: good organ function within 7 days of initial dosing with specified blood and liver function parameters
You will not qualify if you...
- Presence of distant metastasis
- Previous treatment with CTLA4 blockade
- Interstitial lung disease or history of non-infectious pneumonia requiring corticosteroids
- Active autoimmune diseases needing systemic treatment or considered at risk of recurrence, except certain stable conditions
- History of other cancers in the past 5 years except certain cured or low-risk cancers
- Uncontrolled comorbidities including active HBV, HCV with high viral load, HIV/AIDS, active tuberculosis, uncontrolled hypertension, heart failure, unstable angina, recent myocardial infarction, arrhythmias, or active bleeding
- History of allogeneic bone marrow or organ transplant
- Allergic or hypersensitivity reactions to antibody drugs
- Pregnant or lactating females
- For combination treatment candidates: recent gastrointestinal perforation or fistula, major surgery within 28 days, need for systemic corticosteroids or immunosuppressants within 14 days, or unresolved toxicities from prior cancer treatments above Grade 2 except alopecia, skin pigmentation, or certain immune-related conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
Z
Zhenghang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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