MedTrace Logo

Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in Locally Advanced Proximal Stomach Adenocarcinoma

NCT03631615 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-08-26

No results posted yet for this study

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).

Conditions

  • Gastric Adenocarcinoma

Interventions

DRUG

Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210)

Patients will be given the perioperative treatment as below once recruited: 1. induction Neochemotherapy (3w): one cycle of XELOX regimen before surgery; 2. within one week after the induction, concurrent neochemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. 3. consolidation neochemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen; From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given q3W. Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection. Adjuvant chemo: We advise starting 4 cycles of XELOX regimen in 4-6w after surgery.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Tianshu Liu, Doctor · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631615 on ClinicalTrials.gov