Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

NCT06157216 | Active Not Recruiting

• 1 other identifier: MRD-GATE
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Stage II-III Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-Free Survival (DFS) rate

  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 Outcomes (4)

• Rate of De-escalation Treatment

  3-year after the last subject participating in

• Disease-Free Survival (DFS)

  3-year after the last subject participating in

• Cumulative Risk of Recurrence

  3-year after the last subject participating in

• 3-year Overall Survival (OS) Rate

  3-year after the last subject participating in

Other Outcomes (1)

• Association between prognosis with multi-omic sequences

  3-year after the last subject participating in

Study Arms (1)

MRD-guided treatment

EXPERIMENTAL

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

Interventions

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.

MRD-guided treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Shandong Provincial Hospital: collaborator
• Jinan Central Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator

Study Sites (5)

Qilu Hospital of Shandong Univertisy

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250012, China

Location

Jinan Central Hospital

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 5, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 7, 2025

Record last verified: 2024-11

Locations

CN (5)