Registry Study in MSI/dMMR Solid Tumors

October 24, 2023 updated by: Peking University Cancer Hospital & Institute

Multi-center, Non-interventional, Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Medical Oncology, Peking University First Hospital
        • Contact:
          • Xuan Jin
      • Beijing, China
        • Recruiting
        • Department of Oncology, Beijing Luhe Hospital Affiliated to Capital Medical University
        • Contact:
          • Dong Yan
      • Beijing, China
        • Recruiting
        • Department of Oncology, Peking University Shougang Hospital
        • Contact:
          • Xiaodong Wang
      • Tianjin, China
        • Recruiting
        • Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Ting Deng
    • Beijing
      • Beijin, Beijing, China, 100142
        • Recruiting
        • Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute
        • Contact:
          • Zhenghang Wang
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University
        • Contact:
          • Fengbin Zhang
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Department of Oncology, The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Zhiwei Chang
    • Liaoning
      • Shengyang, Liaoning, China
        • Recruiting
        • Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute
        • Contact:
          • Qiwei Wang
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Department of Oncology, The Affiliated Hospital of Qingdao University
        • Contact:
          • Zimin Liu
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital
        • Contact:
          • Hongxia Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort A
Patients will initially receive monotherapy PD1/PDL1 monoclonal antibody therapy.
Cohort B
Patients will initially receive dual blockade of both PD1/PDL1 and CTLA4
Cohort C
Patients will initially receive PD1/PDL1 monoclonal antibody combined with chemotherapy or targeted therapy.
Cohort D
Patients will receive other standard treatments for this tumor other than ICIs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) determined by the researchers according to the RECIST 1.1 criteria..
Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Overall survival
Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Overall response rate
Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation.
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Disease control rate
Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation.
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Treatment-related adverse event
Time Frame: Informed consent to 30 days after last dose of treatment
A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0.
Informed consent to 30 days after last dose of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Director: zhenghang Wang, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2023

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LGH2023093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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