Actively Recruiting
Toripalimab Plus FLOT in Locally Advanced Gastric Cancer
Led by Henan Cancer Hospital · Updated on 2024-06-06
60
Participants Needed
1
Research Sites
392 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemoimmunotherapy for locally advanced gastric and gastroesophageal junction (G/GEJ) cancer is currently under investigation. Most clinical studies have simply combined chemotherapy with anti-PD-1 therapy without considering the impact of chemotherapy drugs on activated immune cells. We designed this study to explore two different treatment regimens for neoadjuvant chemotherapy in patients with locally advanced G/GEJ cancer. One group received FLOT plus toripalimab on Day 1 of each cycle, every 2 weeks for 4 cycles, followed by surgery; the other group received FLOT plus toripalimab on Day 3 of each cycle, every 3 weeks for 3 cycles, followed by surgery. A total of 69 subjects were enrolled. Preliminary statistical analysis conducted one year after the last subject was enrolled revealed no statistically significant differences in pCR and MPR between the two regimens. The median DFS for both groups has not been reached, and there is no statistically significant difference in DFS between the two groups at present. Further subgroup analysis indicated that among subjects with PD-L1 CPS ≥1, the triweekly group achieved a rate of 42.1%, compared to 29.4% in the biweekly group, with no statistically significant difference between the two groups. However, the incidence of bone marrow suppression was lower in the triweekly group than in the biweekly group. Based on the preliminary findings, we plan to conduct an expanded study and transition to a multicenter clinical trial. This study aims to further validate the efficacy of the triweekly chemoimmunotherapy in patients with PD-L1 CPS ≥1 locally advanced G/GEJ cancer.
CONDITIONS
Official Title
Toripalimab Plus FLOT in Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years regardless of gender
- Pathologically confirmed gastric adenocarcinoma
- No distant metastasis and cancer is resectable or potentially resectable as evaluated by surgery experts
- ECOG performance status 0 or 1
- Clinical stage T3 or T4, or positive lymph nodes (N+) by AJCC 8.0
- PD-L1 CPS score 1 or higher (IHC 22C3 pharm Dx assay)
- Expected lifespan over 3 months
- Adequate organ function without growth factor or blood support in first 2 weeks
- Cardiac function with no or mild heart disease
- Liver function within specified limits (TBIL 64 2 ULN, AST 64 2.5 ULN, ALT 64 2.5 ULN)
- Renal function with creatinine 64 1.25 ULN
- Normal or controlled blood pressure
- Controlled fasting blood glucose 64 8 mmol/L if diabetic
- For positive hepatitis B surface antigen, HBV DNA below normal test limits
- No other serious conflicting diseases
- No history of other malignant tumors
- Women of childbearing potential must have negative pregnancy test within 7 days before enrollment and use contraception during and 6 months after the trial
- Signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe infections within 4 weeks before enrollment
- Bronchial asthma requiring intermittent bronchodilators or medical intervention
- Use of immunosuppressants including prednisone 65 10 mg for more than 2 weeks
- Severe cardio-cerebrovascular diseases including recent heart attack, unstable angina, heart failure, arrhythmias requiring treatment, low ejection fraction, or recent stroke
- Allergy to study drugs or severe allergy history
- Severe mental disorders
- Abnormal blood clotting or bleeding disorders or on anticoagulation therapy
- Lung diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or severe lung impairment
- Difficulty swallowing study drugs or chronic diarrhea or intestinal obstruction affecting drug absorption
- History of immunodeficiency including HIV or organ transplant
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
Q
Quanli Gao, M.D
CONTACT
L
Lingdi Zhao, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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