MedTrace Logo

FLOT Combined With PD-1 in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis

NCT04886193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-13

No results posted yet for this study

Summary

In this study, patients with advanced gastric adenocarcinoma whose peritoneal metastasis and peritoneal nodule pathologically confirmed metastasis and/or exfoliative cytology were confirmed as the clinical stage of peritoneal metastasis, who had not received treatment before, were invited to participate in the study.To evaluate the surgical conversion rate and tumor regression grade (TRG grade) of patients with stage gastric cancer with peritoneal metastasis using docetaxel, oxaliplatin, fluorouracil (FLOT regimen) combined with teriprizumab (PD-1).

Conditions

Interventions

DRUG

FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU), Treprizumab, Tiggio capsule (S-1)

* FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ 24h Q2W * Treprizumab 3mg/kg, intravenously administered on the first day of each cycle, Q2W * Tiggio capsule (S-1) 40-60mg (BSA\<1.25 m2: 40mg, 1.25 m2≤BSA≤1.5 m2: 50mg, BSA\> 1.5 m2: 60mg) po bid d1-14 Q3W, continuous treatment for 1 year; * Teriprizumab 240mg, intravenously, given on the first day of each cycle, Q3W, continuous treatment for 1 year.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2022-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886193 on ClinicalTrials.gov