NCT04997837RecruitingPhase 3
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 10 Aug 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 433 (estimated)
- First submitted
- 21 Jul 2021
- Start date
- 21 Jul 2021
- Primary completion date
- 21 Jul 2027
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04997837
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 433
- From 21 Jul 2021 to the primary completion date, 21 Jul 2027
- 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.
Prior treatment
- Patients who has received any anti-tumor therapy before surgery.
- Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc.
- Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication)
Other illness
- Patients who had active systematic autoimmune diseases which need systematic treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded.
- Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material.
- Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal cell carcinoma of the skin and/or radical resected carcinoma in situ.
- Patient with severe vital organ failure.
- Patient with known mental illness or drug abuse that may influence compliance.
- Patient with known HIV infection, or active tuberculosis.
- Untreated active hepatitis B
- Patient with active HCV infection
Other
- Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis.
- Pregnant or lactation period
- Uncontrolled complications
- Other situations that might disturb study results and compliance.
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
- Patients with expected survival time more than 6 months
- Patients after standard D2/R0 resection
- Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ
- Positive lymph nodes more than 7, stage pN3
- Patients without distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0)
- Patients' physical condition and visceral function allows following adjuvant therapy, including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy.
- Patients' blood routine and biochemical indicators should meet the following standard: Hb≥90g/L, ANC≥1.5\*10\^9/L, PLT≥100\*10\^9/L, ALT \& AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine\<1 UNL.
- Patients who are willing to obey regimens during the study.
- Written informed consent is acquired before random entry, and patients should know that he/she has the right to quit, and following treatment won't be affected.
- Patients are willing to provide samples of blood and tissue.
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 |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.