NCT06459921Not yet recruitingPhase 2
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 10 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Xijing Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06459921
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 1 Dec 2024 to the primary completion date, 1 Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Patients refusing surgical resection after preoperative chemotherapy therapy.
- 4\. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
- 11\. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
- 15\. Patients who are not expected to achieve R0 resection.
- 16\. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
- 17\. Patients with multiple factors affecting oral medication.
- 18\. Vaccination within 4 weeks prior to the first dose of study drug.
- 19\. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
Other illness
- 2\. Patients with recurrence of residual gastric cancer
- 5\. Patients with confirmed allergy to the study drug and/or its excipients.
- 6\. Severe malnutrition and active autoimmune diseases.
- 8\. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
- 9\. Patients with acute infections requiring antibiotic treatment.
- 10\. Patients with acute infections requiring antibiotic treatment.
- 12\. Positive test result for hepatitis B or hepatitis C virus.
- 14\. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
- 20\. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
Other
- 1\. Locally advanced unable to resect or metastatic tumors.
- 7\. Pregnant or lactating women.
- 13\. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1).
Who the study is looking for
- 1\. Age \>=18 years and \<100 years.
- 2\. Diagnosed with locally advanced gastric cancer.
- 3\. Eastern Cooperative Oncology Group ECOG PS score 0-1.
- 4\. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
- 5\. deficient mismatch repair identified by pathological detection.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.