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

NCT05000554 | Recruiting Phase 2

• 1 other identifier: STARS-GC02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

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

  30 days

Secondary Outcomes (5)

• ORR

  30 days

• PFS

  3 years

• OS

  3 years

• postoperative complication

  Up to 30 days post-operative

• operative mortality

  Up to 30 days post-operative

Study Arms (1)

Locally advanced gastric cancer

EXPERIMENTAL

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

Procedure: Neoadjuvant Therapy

Interventions

Neoadjuvant Therapy PROCEDURE

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

Locally advanced gastric cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Di Guo

CONTACT

0431-88782013; guodi17790060921@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 11, 2021
• Study Start: July 2, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)