Trial Title:
Registry Study in MSI/dMMR Solid Tumors
NCT ID:
NCT06004713
Condition:
DMMR Cancer
MSI-H
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This study is a multi-center, non-interventional, prospective clinical observational
study, aiming to evaluate the effectiveness and safety of subsequent treatment in
dMMR/MSI solid tumor patients who have never received ICIs under real-world conditions.
Particular attention is paid to the efficacy in populations where treatment plans are
adjusted based on ctDNA, and potential predictive or prognostic biomarkers are explored.
Detailed description:
This study plans to enroll patients in the following four cohorts:
- Cohort A: Initially only receiving PD1/PDL1 monotherapy;
- Cohort B: Initially receiving simultaneous blockade of PD1/PDL1 and CTLA4;
- Cohort C: Initially receiving PD1/PDL1 monotherapy combined with chemotherapy or
targeted therapy;
- Cohort D: Initially not using ICIs, receiving other standard treatments for this
tumor type
To explore the role of ctDNA testing in therapeutic decision-making, patients with the
first evaluation of SD in cohort A are divided into two groups: ctDNA
testing/intervention group (Group A1) and ctDNA testing/non-intervention group (Group
A2). In group A1, if there is no early response to ctDNA, the researchers and the patient
will decide to add CTLA4 antibody or other potentially effective treatments after
thorough communication. If there is an early response to ctDNA, then continue with
PD1/PDL1 monoclonal antibody treatment. Patients in group A2 undergo ctDNA testing, but
still continue with PD1/PDL1 monoclonal antibody treatment according to the RECIST v1.1
standard when the first evaluation of SD is made. Meanwhile, explore the role of 1-year
ctDNA-MRD in guiding treatment in patients with long-term tumor control, and explore the
guiding role of re-biopsy of tumor tissue or ctDNA testing in helping making treatment
regimen after progression on ICIs.
Number of Subjects:
• This study will recruit patients nationwide for data collection over a period of 3
years. The plan is to enroll 100 cases in Cohort A, including 25 cases in Group A1 and 25
cases in Group A2; 30 cases in Cohort B; 30 cases in Cohort C; and 30 cases in Cohort D.
Criteria for eligibility:
Study pop:
The estimated start time of this study is August 2023, and data will be collected from
enrolled patients nationwide over a period of 3 years. It is planned to enroll 100
patients in Cohort A, including 25 in Group A1 and 25 in Group A2. It is planned to
enroll 30 patients in Cohort B, 30 in Cohort C, and 30 in Cohort D.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute
Address:
City:
Beijin
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenghang Wang
Facility:
Name:
Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Fengbin Zhang
Facility:
Name:
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiwei Chang
Facility:
Name:
Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute
Address:
City:
Shengyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiwei Wang
Facility:
Name:
Department of Oncology, The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Zimin Liu
Facility:
Name:
Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongxia Lu
Facility:
Name:
Department of Medical Oncology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuan Jin
Facility:
Name:
Department of Oncology, Beijing Luhe Hospital Affiliated to Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Yan
Facility:
Name:
Department of Oncology, Peking University Shougang Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaodong Wang
Facility:
Name:
Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Deng
Start date:
October 7, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06004713
