Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

November 27, 2023 updated by: Qilu Hospital of Shandong University

Circulating Tumor DNA Minimal Residual Disease-guided Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer

This is a multicenter, single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

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

  • Name: Lian Liu, M.D., Ph.D.
  • Phone Number: +8653182169851
  • Email: tounao@126.com

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Meili Sun
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong Univertisy
        • Contact:
        • Contact:
          • Lian Liu, M.D., Ph.D.
          • Phone Number: 053182169851
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Yantai, Shandong, China, 264000

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

Description

Inclusion Criteria:

  1. Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
  2. No preoperative neoadjuvant or adjuvant therapy received.
  3. Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
  4. Age between 18-75 years, with no gender restrictions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  6. Estimated survival of 6 months or more.
  7. Baseline hematological and biochemical parameters within specified limits: a. Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10^9/L. c. Platelet count ≥ 100×10^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal, T3 and T4 levels must be normal).

Exclusion Criteria:

  1. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
  2. Evidence of postoperative recurrence or metastasis.
  3. Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
  4. Positive resection margins identified in postoperative pathology.
  5. History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
  6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
  7. Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
  8. Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
  9. Allergic reactions to study drugs.
  10. Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
  11. Administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period.
  12. Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
  13. Positive for COVID-19 nucleic acid or antigen test.
  14. Other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRD-guided treatment
Patients post-surgery will receive MRD tests and receive MRD-guided adjuvant therapies. After that, MRD status will be continuously monitored for three years to guide the following therapies.
Drug: MRD-guided therapy
MRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2，PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Disease-Free Survival (DFS) rate
Time Frame: 3-year after the last subject participating in
The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.
3-year after the last subject participating in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of De-escalation Treatment
Time Frame: 3-year after the last subject participating in
The Rate of De-escalation Treatment is defined as the proportion of patients among a study population who receive a reduction in the intensity or scope of therapeutic interventions.
3-year after the last subject participating in
Disease-Free Survival (DFS)
Time Frame: 3-year after the last subject participating in
Disease-Free Survival (DFS) is defined as the duration of time from the initiation of surgery until the recurrence of the disease or death from any cause, whichever comes first.
3-year after the last subject participating in
Cumulative Risk of Recurrence
Time Frame: 3-year after the last subject participating in
The Cumulative Risk of Recurrence is defined as the cumulative probability or risk of disease recurrence over a specified period, considering the entire study population.
3-year after the last subject participating in
3-year Overall Survival (OS) Rate
Time Frame: 3-year after the last subject participating in
3-year Overall Survival (OS) Rate is defined as the percentage of patients who are still alive three years after the initiation of a specific treatment, regardless of disease recurrence or progression.
3-year after the last subject participating in

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between prognosis with multi-omic sequences
Time Frame: 3-year after the last subject participating in
Association between prognosis with multi-omics data, including whole-exome sequencing, RNA sequencing, etc.
3-year after the last subject participating in

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

Collaborators

The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
Jinan Central Hospital
Yantai Yuhuangding Hospital

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 1, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRD-GATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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