NCT05602935Active, not recruitingPhase 2
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
Source: ClinicalTrials.gov · Last updated 28 Sept 2023
Brief summary (registry, in English)
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 24 Oct 2022
- Start date
- 16 Sept 2020
- Primary completion date
- 30 Mar 2022
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05602935
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 29
- From 16 Sept 2020 to the primary completion date, 30 Mar 2022
- 1 site in 1 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.
Other illness
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
- Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
- With any mental illness;
Other
- Unresectable tumor evaluated by investigator;
- With tumors in other sites;
- Pregnant or lactating women.
Who the study is looking for
- Age older than 18 years of age;
- Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
- Without prior systematic therapy;
- The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
- With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
- Life expectancy longer than 12 months;
- Adequate function of blood, heart, liver, kidney and thyroid.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.