This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus Concomitant Chemoradiotherapy in patients with Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. 33 participants with Initial Unresectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) will be treated with conversion therapy as below once recruited: 1. induction chemotherapy (3w): one cycle of camrelizumab 200mg q3w and SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14,Q3w); 2. after the induction, concurrent Chemoradiotherapy will be started (5-6w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas, total dose:45Gy/25d, 1.8Gy/d, camrelizumab 200mg q3w, S-1 40-60mg bid, d1-d14, Q3w. The resectability assessment will be performed followed by MDT. 3. Participants still unresectable will receive additional conversion therapy with camrelizumab and SOX regimen. The resectability will be evaluated every 6 weeks until resectable or up to 8 cycles of conversion therapy. Resectable patients will receive D2 resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Camrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d
1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment
PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
Time frame: Up to approximately 12 months
progression-free survival (PFS) according to RECIST 1.1 base on investigator assessment
PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment.
Time frame: Up to approximately 36 months
disease-free survival (DFS) Per RECIST 1.1 base on investigator assessment
DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by investigators in patients undergoing surgery.
Time frame: Up to approximately 36 months
rate of R0-resections
the percentage of participants undergoing surgery with resection margin status negative.
Time frame: Up to 30 days post-sugery
Major pathological response(MPR)
The proportion of participants with a major pathological response (mPR) at the time of definitive surgery.
Time frame: Up to 30 days post-sugery
Pathological Complete Response (pCR)
Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response at the time of definitive surgery.
Time frame: Up to 30 days post-sugery
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Overall Survival (OS)
OS is the time from the first dose to death due to any cause.
Time frame: Up to 5 years
Percentage of Participants Experiencing An Adverse Event (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocolspecified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. The grade of AE will be assessed per CTCAE 5.0.
Time frame: Up to approximately12 months