Registry Study in MSI/dMMR Solid Tumors

NCT06004713 | Recruiting

• 1 other identifier: LGH2023093
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

DMMR Cancer; MSI-H; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) determined by the researchers according to the RECIST 1.1 criteria..

  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 Outcomes (5)

• Overall survival

  Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose

• Overall response rate

  Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose

• Disease control rate

  Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose

• Duration of response

  Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose

• Treatment-related adverse event

  Informed consent to 30 days after last dose of treatment

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (10)

Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute

Beijin, Beijing Municipality, 100142, 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

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Biospecimen

Retention: SAMPLES WITH DNA

1. Blood sample collection: Collect 10mL of peripheral blood in a purple EDTA-K2 anticoagulant blood collection tube. If the blood plasma cannot be separated within the specified time, a Streck (EDTA-K3) blood collection tube can be used, and the patient's name, sample type, and collection time should be marked on the tube wall. 2. Plasma Separation: Whole blood samples are centrifuged at 4°C or room temperature, at 1800g for 10 minutes. Except for 0.5mL of whole blood reserved, all the whole blood is separated into plasma as much as possible. After centrifugation, carefully collect the upper layer of plasma into a new, labeled 5mL low-adsorption centrifuge tube, and finally seal with a sealing film for future use.

Study Officials

• zhenghang Wang

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

zhenghang Wang

CONTACT

18813186790; zhenghang_wang@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: October 7, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)