Back to results

The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Neoadjuvant Therapy

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
No bulky lymph node metastasis is detected by abdominal CT.
No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
No clinically apparent distant metastasis.
Karnofsky performance status ≥70%.
Sufficient oral intake.
No previous treatment with chemotherapy or radiation therapy for any tumors.
No previous surgery for the present disease.
Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
No need for emergency surgery due to bleeding or perforation of the primary tumor.
No mechanical obstruction.
Written informed consent.

Exclusion Criteria:

Past history of upper abdominal surgery.
Past history of surgery for the gastrointestinal tract.
Body mass index exceeding 30 kg/m2.

Sites / Locations

the First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Locally advanced gastric cancer

Arm Description

Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy

Outcomes

Primary Outcome Measures

pCR rate

Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.

Secondary Outcome Measures

ORR

defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.

PFS

Defined as the time from the start of randomization to the progression of the disease or the death of the patient.

Defined as the time between the beginning of randomization and the death of the patient for any reason.

postoperative complication

Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system.

operative mortality

Defined as death of any cause within 30 days of surgery.

Full Information

NCT ID

NCT05000554

First Posted

June 28, 2021

Last Updated

August 3, 2021

Sponsor

The First Hospital of Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT05000554

Brief Title

The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

Official Title

The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 2, 2021 (Actual)

Primary Completion Date

March 1, 2026 (Anticipated)

Study Completion Date

June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Locally advanced gastric cancer

Arm Type

Experimental

Arm Description

Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy

Intervention Type

Procedure

Intervention Name(s)

Neoadjuvant Therapy

Intervention Description

Drug: Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25~1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14； Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection

Primary Outcome Measure Information:

Title

pCR rate

Description

Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

ORR

Description

defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.

Time Frame

30 days

Title

PFS

Description

Defined as the time from the start of randomization to the progression of the disease or the death of the patient.

Time Frame

3 years

Title

Description

Defined as the time between the beginning of randomization and the death of the patient for any reason.

Time Frame

3 years

Title

postoperative complication

Description

Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system.

Time Frame

Up to 30 days post-operative

Title

operative mortality

Description

Defined as death of any cause within 30 days of surgery.

Time Frame

Up to 30 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1). Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved. No bulky lymph node metastasis is detected by abdominal CT. No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT. No clinically apparent distant metastasis. Karnofsky performance status ≥70%. Sufficient oral intake. No previous treatment with chemotherapy or radiation therapy for any tumors. No previous surgery for the present disease. Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl No need for emergency surgery due to bleeding or perforation of the primary tumor. No mechanical obstruction. Written informed consent. Exclusion Criteria: Past history of upper abdominal surgery. Past history of surgery for the gastrointestinal tract. Body mass index exceeding 30 kg/m2.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Di Guo

Phone

0431-88782013

guodi17790060921@126.com

Facility Information:

Facility Name

the First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Di Guo

Phone

0431-88782013

guodi17790060921@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

We'll reach out to this number within 24 hrs