A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage II/III Gastric or GE Junction Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Gastric Cancer Stage II
- Sponsor
- Aiping Zhou
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Major pathological response rate
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, siwert type I was excluded.
- •Clinical determined T3/4 N any or T 1/2 N 2/3 referred to AJCC 8, based on CT, gastroscopy, endoscopic ultrasound, gastrointestinal angiography, general ultrasound, or laparoscope if the patient can afford.
- •No prior chemotherapy and/or immunotherapy and/or radiation therapy.
- •Age 18 to 75 years old.
- •ECOG 0 or 1 .
- •Adequate Organ Function Laboratory Values Hb≥90g/L, WBC≥3.5×109 /L, ANC≥1.5×109 /L, Platelets≥100×109 /L Serum creatinine ≤1.0×ULN ALT≤1.5 ×UNL , AST ≤1.5×ULN，ALP≤ 1.5 ×ULN Serum total bilirubin ≤1.5 × ULN
- •Signed Informed consent
Exclusion Criteria
- •Pathology types other than adenocarcinoma, such as squamous cell carcinoma.
- •intra-abdominal dissemination or distant metastasis (M1).
- •Digestive tract obstruction or repeated bleeding which can not be controlled, clinically significant ascites.
- •Those who cannot swallow pills.
- •Cirrhosis caused by any cause.
- •Heart function NYHA \> I degree
- •Previous myocardial infarction, unstable angina, stroke and uncontrolled arrhythmia.
- •with any contraindications for surgery.
- •Previously received chemotherapy and or radiation therapy.
- •Previously received any anti-PD 1 , anti - PD L1/L2 antibodies, anti-CTLA 4 antibodies and other immunotherapy.
Arms & Interventions
XELOX combined with Toripalimab
Intervention: Toripalimab
XELOX combined with Toripalimab
Intervention: oxaliplatin
XELOX combined with Toripalimab
Intervention: capecitabine
Outcomes
Primary Outcomes
Major pathological response rate
Time Frame: Up to 6 months
Proportion of subjects with residual tumor less than 10% or complete response
Secondary Outcomes
- Incicende of Adverse Events (AEs)(Up to 6 months)
- Pathologic Complete Response (pCR) Rate(Up to 6 months)
- Overall Response Rate (ORR)(Up to 6 months)
- Disease Free Survival (DFS)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)