Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy. PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.
This phase II trial is a single-arm, open Label, non-randomized and single-center clinical study. Patients who met the study criteria will receive the combination of toripalimab (240 mg d1) with XELOX (oxaliplatin 130 mg/m2 QD, d1, capecitabine 1000 mg/m2 BID, d1-d14) of a 3-week treatment cycle up to two cycles. After the second cycle of treatment, clinical efficacy evaluation will be done by MDT according to iRECIST. For patients with CR/PR/SD, surgery will be performed within 4 weeks. For patients with disease progress, MDT will determine whether the surgery could be performed. If resection could not be done, the patients would receive Original chemotherapy with toripalimab for 1 more cycle, chemoradiotherapy or the second line chemotherapy. The primary endpoint is Major pathological response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
toripalimab 240 mg d1; q3w, up to two cycles.
oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles
apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChinese Academy of Medical Sciences
Beijing, China
RECRUITINGMajor pathological response rate
Proportion of subjects with residual tumor less than 10% or complete response
Time frame: Up to 6 months
Incicende of Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
Time frame: Up to 6 months
Pathologic Complete Response (pCR) Rate
Proportion of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.
Time frame: Up to 6 months
Overall Response Rate (ORR)
Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) according to iRECIST
Time frame: Up to 6 months
Disease Free Survival (DFS)
Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.
Time frame: Up to 5 years
Overall Survival (OS)
Time from Cycle 1 Day 1 treatment administration to death due to any cause.
Time frame: Up to 5 years
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