Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in Locally Advanced Proximal Stomach Adenocarcinoma
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
1. Target population: patients with resectable locally advanced proximal (including
gastroesophageal junction, fundus and upper body) stomach adenocarcinoma (cT3-4aN+M0).
2. Primary objective: pathological complete remission (pCR) rate of neoadjuvant
chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal
stomach adenocarcinoma.
Secondary objectives:
1. pathological remission rate (pRR) of neoadjuvant chemoradiation plus PD-1 antibody
(SHR-1210)
2. objective response rate (ORR) of neoadjuvant chemoradiation plus PD-1 antibody
(SHR-1210)
3. progression free survival (PFS)/ overall survival (OS) of neoadjuvant chemoradiation
plus PD-1 antibody (SHR-1210)
4. safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and
safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally
advanced proximal stomach adenocarcinoma.
4.Treatment plan:
Patients will be given the perioperative treatment as below once recruited:
1. induction chemotherapy (3w): one cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d
+ oxaliplatin 130mg/m2, d1, Q21d);
2. within one week after the induction, concurrent chemoradiation will be started (5w):
intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage
areas, total dose:45Gy/25d, 1.8Gy/d, capecitabine (850 mg/m2, bid, po) will be given
during radiotherapy as sensitizer.
3. consolidation chemotherapy will be started in 2-3w after concurrent chemoradiation: one
cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1,
Q21d); From the beginning of induction chemo to 3w before surgery, PD-1 antibody
SHR-1210 will be given（200mg, iv, q3w).
Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will
receive D2 resection.
Adjuvant chemo: We advice starting 4 cycles of XELOX regimen (capecitabine 1000 mg/m2 bid*14d
+ oxaliplatin 130mg/m2, d1, Q21d) in 4-6w after surgery.
5.Number of subjects: 36 patients. Number of centers: 1 sites ( Fudan University Affiliated
Zhongshan Hospital, which has high volume of gastric operations in China, more than 500 per
year).