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Evaluation of the effect of circulating tumor ctDNA detection on neoadjuvant therapy for gastric cancer: a single arm multicenter prospective observational study

Evaluation of the effect of circulating tumor ctDNA detection on neoadjuvant therapy for gastric cancer: a single arm multicenter prospective observational study

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060842
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

CtDNA detection group: CtDNA detection

Sponsors

Department of gastrointestinal surgery, the First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. It is expected to complete radical D2 lymph node dissection (the number of lymph nodes examined must be at least 15 to ensure the quality of the operation). 2. Physical condition and organ function allow large abdominal surgery. 3. Willing and able to follow the protocol during the study. 4. Provide written informed consent before entering the study screening, and the patient has learned that he can withdraw from the study at any time without any loss. 5. Patients aged 18-70 years with gastric adenocarcinoma confirmed by pathology before operation. The total course of chemotherapy and adjuvant chemotherapy were 6 months, and the survival period was expected to be > 6 months. 7. No other serious concomitant diseases and good organ function. 8. There are no medical contraindications that seriously affect anesthesia and surgery. 9. Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy); 10. The 8th Edition AJCC stage is ct3-4an1-3m0 gastric cancer patients. 11. The blood routine examination standard shall meet the following standards: a WBC>4.0 × 10/L b. ANC>1.5 × 10/L c. ANC >= 1.5 × 10^9/L d. HB >= 80 g/L e. PLT >= 100 × 10^9/L 12. Biochemical examination shall meet the following standards: a TBIL= 50 mL/ min (Cockcroft Gault formula). 13. No history of upper abdominal surgery (except laparoscopic cholecystectomy); No history of peritonitis and pancreatitis. 14. There are no other serious diseases that make the survival time 60; ECoG score: 0-2. 16. No history of other tumors

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women who are in the reproductive period and do not take effective contraceptive measures. 2. Complicated with serious medical diseases or conditions: such as clinically serious (i.e. active) heart disease, serious and uncontrolled medical diseases and infections, serious uncontrollable digestive system disorders, serious electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, lung, liver, kidney failure, peripheral neuropathy, etc., unable to tolerate D2 radical gastrectomy. 3. Organ transplantation requires immunosuppressive therapy. 4. Serious uncontrolled repeated infection or other serious uncontrolled concomitant diseases. 5. History of other malignant tumors within 5 years from the start of the trial, except cured skin basal cell carcinoma and cervical carcinoma in situ. 6. Patients without self-knowledge ability and mental disorders. 7. Have a history of organ transplantation (including bone marrow autotransplantation and peripheral stem cell transplantation). 8. Use other test drugs at the same time or in other clinical trials. 9. Those who have received biological therapy or other anti-cancer traditional Chinese medicine with an interval of less than 4 weeks. 10. HER-2 test is positive or esophageal gastric junction adenocarcinoma, patients who are willing to receive Herceptin treatment or patients with indications and willingness to receive immunotherapy; 11. Postoperative chemotherapy is not acceptable. 12. Patients with peripheral neuropathy nct-ctcae >= grade 2; 13. Tumor recidivism surrounding organs (T4b) or combined with distant metastasis. 14. For those who are allergic to the drugs in this study protocol, the researcher determines that they are not suitable for participating in this clinical study.

Design outcomes

Primary

MeasureTime frame
Changes of blood ctDNA value;

Secondary

MeasureTime frame
Overall survival;Progress Free Survival;

Countries

China

Contacts

Public ContactJigang
Inte1385@163.com+86 029 84771533

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026