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NCT Number: NCT06157216

Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

This is a 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinan Central Hospital, Jinan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
  • No preoperative neoadjuvant or adjuvant therapy received.
  • Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
  • Age between 18-75 years, with no gender restrictions.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated survival of 6 months or more.
  • 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

  • Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
  • Evidence of postoperative recurrence or metastasis.
  • Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
  • Positive resection margins identified in postoperative pathology.
  • History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
  • Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
  • Allergic reactions to study drugs.
  • Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
  • 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.
  • Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
  • Positive for COVID-19 nucleic acid or antigen test.
  • 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.

Treatment and study plan

MRD-guided therapy

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Dec 5, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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