RecruitingPhase 2NCT05000554

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


Sponsor

The First Hospital of Jilin University

Enrollment

30 participants

Start Date

Jul 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria14

  • 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 Criteria3

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

Interventions

PROCEDURENeoadjuvant Therapy

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


Locations(1)

the First Hospital of Jilin University

Changchun, Jilin, China

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NCT05000554


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