Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631615
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2018-08-13
Brief Title:
Neoadjuvant Chemoradiation Plus PD-1 AntibodySHR-1210 in Locally Advanced Proximal Stomach Adenocarcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A Phase II Study of Neoadjuvant Chemoradiation Plus PD-1 AntibodySHR-1210 in the Locally Advanced Proximal Stomach Adenocarcinoma Neo-PLANET
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neo-PLANET
Brief Summary:
1 Target population patients with resectable locally advanced proximal including gastroesophageal junction fundus and upper body stomach adenocarcinoma cT3-4aNM0
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
3Trial 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
4Treatment plan
Patients will be given the perioperative treatment as below once recruited
1 induction chemotherapy 3w one cycle of XELOX regimen capecitabine 1000 mgm2 bid14d oxaliplatin 130mgm2 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 dose45Gy25d 18Gyd capecitabine 850 mgm2 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 mgm2 bid14d oxaliplatin 130mgm2 d1 Q21d From the beginning of induction chemo to 3w before surgery PD-1 antibody SHR-1210 will be given200mg 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 mgm2 bid14d oxaliplatin 130mgm2 d1 Q21d in 4-6w after surgery
5Number 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
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
3Trial 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
4Treatment plan
Patients will be given the perioperative treatment as below once recruited
1 induction chemotherapy 3w one cycle of XELOX regimen capecitabine 1000 mgm2 bid14d oxaliplatin 130mgm2 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 dose45Gy25d 18Gyd capecitabine 850 mgm2 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 mgm2 bid14d oxaliplatin 130mgm2 d1 Q21d From the beginning of induction chemo to 3w before surgery PD-1 antibody SHR-1210 will be given200mg 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 mgm2 bid14d oxaliplatin 130mgm2 d1 Q21d in 4-6w after surgery
5Number 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
Detailed Description:
Backgrounds
SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co Nowadays fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor including one combined with radiotherapy and three combined with chemotherapy Until now SHR-1210 has exhibited favorable safety in recruited patients Incidence rate of SAE is only 1
Several big scale clinical research like POET RTOG 9904 and TOPGEAR have proofed the efficacy and safety of neoadjuvant chemoradiation in treating locally advanced GEJ cancer or gastric cancer
Study design
This clinical trial will be conducted under Simons optimal two-stage design The first stage needs 15 participants if 1 participants acquire remission then the study will move on to the second stage and enroll the rest 21 participants The total sample size will be 36 patients
We will shut down the study in advance if situations below happens 1 1 treatment related death 3 disease progression or 2 hyper-progressive disease happen during the first stage 2 2 treatment related death 6 disease progression or 4 hyper-progressive disease happen during the whole study
Patients with abnormal autoimmune status unfavorable body function factors impeding drug taking absorption and metabolism will be excluded Study participants with disease progression or severe intolerant toxicity during treatment will withdraw the study
Hyper-progressive disease is defined as 1 progression 2 more than doubled growth rate 3 tumor volume increase 50 in 2 months after initialing the treatment
SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co Nowadays fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor including one combined with radiotherapy and three combined with chemotherapy Until now SHR-1210 has exhibited favorable safety in recruited patients Incidence rate of SAE is only 1
Several big scale clinical research like POET RTOG 9904 and TOPGEAR have proofed the efficacy and safety of neoadjuvant chemoradiation in treating locally advanced GEJ cancer or gastric cancer
Study design
This clinical trial will be conducted under Simons optimal two-stage design The first stage needs 15 participants if 1 participants acquire remission then the study will move on to the second stage and enroll the rest 21 participants The total sample size will be 36 patients
We will shut down the study in advance if situations below happens 1 1 treatment related death 3 disease progression or 2 hyper-progressive disease happen during the first stage 2 2 treatment related death 6 disease progression or 4 hyper-progressive disease happen during the whole study
Patients with abnormal autoimmune status unfavorable body function factors impeding drug taking absorption and metabolism will be excluded Study participants with disease progression or severe intolerant toxicity during treatment will withdraw the study
Hyper-progressive disease is defined as 1 progression 2 more than doubled growth rate 3 tumor volume increase 50 in 2 months after initialing the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None