Efficacy and Safety of SOX Regimen Combined With Camreliz... | NCT05602935

Studies
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

NCT05602935

Sponsor

The Second Affiliated Hospital of Fujian Medical University

Status

Active, not recruiting

Last Update Posted

Sep 28, 2023Actual

Enrollment

29Estimated

Phase

Phase 2

Conditions

Stomach Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Stomach Diseases
Neoplasms by Site

Interventions

Camrelizumab
SOX
Surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2020Actual

Primary Completion Date

Mar 30, 2022Actual

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Oct 24, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Description Module

Brief Summary

This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Camrelizumab+SOX	Experimental	The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).	Drug: Camrelizumab Drug: SOX Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Camrelizumab	Drug	200mg, intravenously, d1	Camrelizumab+SOX
SOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathologic complete response (pCR) rate	The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)	2-4 months

Secondary Outcomes

Measure	Description	Time Frame
R0 resection rate		2-4 months
Overall response rate(ORR)		2-4 months
Disease control rate(DCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age older than 18 years of age;
Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
Without prior systematic therapy;
The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
Life expectancy longer than 12 months;
Adequate function of blood, heart, liver, kidney and thyroid.

Exclusion Criteria:

History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
Unresectable tumor evaluated by investigator;
Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
With tumors in other sites;
History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
With any mental illness;
Pregnant or lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Fujian Medical University		Fuzhou	Fujian		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38400680	Derived	Zhong WJ, Lin JA, Wu CY, Wang J, Chen JX, Zheng H, Ye K. Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study. Cancer Med. 2024 Feb;13(3):e7006. doi: 10.1002/cam4.7006.

ID	Term
D005770	Gastrointestinal Neoplasms
D005767	Gastrointestinal Diseases

ID	Term
C000631724	camrelizumab
D013514	Surgical Procedures, Operative

ID	Term
D013274	Stomach Neoplasms
D004067	Digestive System Neoplasms
D009369	Neoplasms
D004066	Digestive System Diseases
D013272	Stomach Diseases
D009371	Neoplasms by Site