Observational study on treatments for dMMR/MSI solid tumors
Multi-center, Non-interventional, Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability
This study is testing how well different treatments work for people with certain solid tumors that haven't been treated with immune therapies yet, while also looking at how blood tests can help guide their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Beijin, Beijing and 9 other locations) |
| Trial ID | NCT06004713 on ClinicalTrials.gov |
What this trial studies
This multi-center, non-interventional observational study aims to evaluate the effectiveness and safety of subsequent treatments in patients with dMMR/MSI solid tumors who have not previously received immune checkpoint inhibitors (ICIs). The study will enroll patients into four cohorts based on their initial treatment regimens, including monotherapy and combination therapies. Additionally, the role of circulating tumor DNA (ctDNA) testing in guiding treatment decisions will be explored, particularly in patients showing stable disease. The study will collect data over three years to assess real-world treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with histologically confirmed dMMR or MSI solid tumors who can receive anti-tumor treatment.
Not a fit: Patients with other malignant tumors within the past five years or those with evidence of disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment strategies for patients with dMMR/MSI solid tumors, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for treatment decision-making in cancer, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sign the informed consent form and voluntarily participate in this study; * Age ≥ 18 years old; age should also be ≤75 years old in Cohorts B, C, D; * Histologically or cytologically confirmed to have a solid malignant tumor and confirmed by immunohistochemistry to be dMMR or confirmed by PCR/NGS to be MSI; * The researcher determines that the patient can receive anti-tumor treatment; * Have evaluable lesions Exclusion Criteria: * Other malignant tumors within 5 years before joining the study, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6 points, and prostate cancer diagnosed with PSA ≤10 ng/mL (if measured). Patients who have received radical treatment and have no prostate specific antigen (PSA) biochemical recurrence can participate in this study), cervical/breast carcinoma in situ, and Lynch syndrome; * Evidence already exists that the patient is a pregnant or lactating woman; * Previous treatment with immune checkpoint inhibitors or T cell co-stimulatory drugs, including but not limited to PD1, CTLA4, LAG3, and other immune checkpoint blockers, therapeutic vaccines, etc.; patients exposed to ICIs in perioperative setting are allowed to be enrolled if disease relapse after more than 6 months since the last dose of ICIs; * Other situations deemed by the researcher to be unsuitable for inclusion in the study
Where this trial is running
Beijin, Beijing and 9 other locations
- Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute — Beijin, Beijing, China (Recruiting)
- Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
- Department of Oncology, The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute — Shengyang, Liaoning, China (Recruiting)
- Department of Oncology, The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
- Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
- Department of Medical Oncology, Peking University First Hospital — Beijing, China (Recruiting)
- Department of Oncology, Beijing Luhe Hospital Affiliated to Capital Medical University — Beijing, China (Recruiting)
- Department of Oncology, Peking University Shougang Hospital — Beijing, China (Recruiting)
- Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: zhenghang Wang
- Email: zhenghang_wang@bjmu.edu.cn
- Phone: 18813186790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.