Actively Recruiting
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
Led by Fudan University · Updated on 2021-08-10
433
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
- Expected survival time more than 6 months
- Patients after standard D2/R0 resection
- Postoperative histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Positive lymph nodes more than 7, stage pN3
- No distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0)
- Physical condition and organ function suitable for chemotherapy, chemoradiotherapy, and PD-1 inhibitor therapy
- Blood tests meeting specified thresholds: 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
- Willingness to follow study treatments
- Signed informed consent and awareness of right to withdraw without affecting treatment
- Willingness to provide blood and tissue samples
You will not qualify if you...
- Presence of gross peritoneal metastasis (except CY1P0) or distant metastasis
- Previous anti-tumor therapy before surgery
- Prior radiotherapy to abdominal organs such as stomach, liver, or kidney
- Active systemic autoimmune diseases requiring treatment within 2 years before study
- Immunodeficiency or recent systemic glucocorticoid or immunosuppressive therapy within 7 days before study, except physiological doses
- Known severe allergic reactions (level 3 or higher) to anti-PD-1 antibodies, 5-FU, Oxaliplatin, or related materials
- Diagnosis of other malignancies in past 5 years except certain skin or carcinoma in situ cancers
- Severe vital organ failure
- Pregnancy or lactation
- Known mental illness or drug abuse affecting compliance
- Known HIV infection or active tuberculosis
- Untreated active hepatitis B or active hepatitis C infection
- Uncontrolled medical complications
- Other conditions that could affect study results or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhen Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here