Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

Stage II-III Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157216
• Other study ID #: MRD-GATE
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: April 1, 2029

Study information

• Verified date: November 2023
• Source: Qilu Hospital of Shandong University
• Contact: Lian Liu, M.D., Ph.D.
• Phone: +8653182169851
• Email: tounao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm, Residual
• Stage II-III Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong Univertisy	Jinan	Shandong
China	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Yantai Yuhuangding Hospital	Yantai	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Jinan Central Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between prognosis with multi-omic sequences	Association between prognosis with multi-omics data, including whole-exome sequencing, RNA sequencing, etc.	3-year after the last subject participating in
Primary	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	Rate of De-escalation Treatment	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
Secondary	Disease-Free Survival (DFS)	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
Secondary	Cumulative Risk of Recurrence	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
Secondary	3-year Overall Survival (OS) Rate	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