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

Primary Purpose

Chemotherapy, Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Chemotherapy focused on measuring FLOT, PD-1, Gastric cancer, Peritoneal metastasis

Eligibility Criteria

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

Inclusion Criteria:

Informed consent of the patient;
18 years old <age <80 years old;
The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathology (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por);
The clinical stage of laparoscopic exploration is peritoneal metastasis, peritoneal nodule pathologically confirmed metastasis and/or exfoliated cytology test positive for advanced gastric cancer patients;
Preoperative ECOG [Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)] Physical State Score 0/1;
Preoperative anesthesia risk score sheet (ASA score sheet) I-III;

Exclusion Criteria:

The pathology of the peritoneal nodule confirmed no metastasis, and the exfoliated cytology test was negative;
Pregnant or lactating women;
Suffer from severe mental illness;
Preoperative imaging or intraoperative exploration revealed that there have been distant blood metastases in the liver, lungs, and brain;
A history of other malignant diseases within 5 years;
A history of allergies to any component of teriprizumab, docetaxel, oxaliplatin, and fluorouracil;
A history of continuous systemic corticosteroid therapy within 1 month;
Complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
A history of unstable angina or myocardial infarction, or a history of cerebral infarction or cerebral hemorrhage within 6 months, and a lung function test FEV1 <50% of the expected value;
Have received any of the following treatments:
1. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
2. Have received any investigational drug treatment within 4 weeks before using the drug for the first time;
3. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
4. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;
5. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration;
6. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time.

Sites / Locations

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLOT combined with PD-1

Arm Description

The enrolled patients will receive 4 cycles of FLOT regimen + teriprizumab treatment before surgery Q2W. If the transformation is successful, the patient undergoes R0 surgical resection of D2 lymph node dissection, and will continue to receive 4 cycles of FLOT regimen + Teripril after surgery. Anti-treatment, the treatment plan is the same as before. After completing the 4 cycles of treatment, oral Tiggio Capsule (S-1) and Teriprizumab were maintained for 1 year.

Outcomes

Primary Outcome Measures

Surgical conversion rate

defined as the proportion of patients who have undergone R0 surgical resection after multidisciplinary assessment after completing 4 courses of conversion adjuvant therapy

TRG grade

tumor regression grade

Secondary Outcome Measures

PFS

Progression-free survival

overall survival

the incidence and severity of adverse events

Full Information

NCT ID

NCT04886193

First Posted

May 10, 2021

Last Updated

May 10, 2021

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborators

Shanghai Junshi Bioscience Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04886193

Brief Title

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

Official Title

Docetaxel, Oxaliplatin, Fluorouracil (FLOT Regimen) Combined With Teriprizumab (PD-1) in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis: an Open, One-arm, Exploratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 16, 2021 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborators

Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

Detailed Description

The study drugs in this study are docetaxel, oxaliplatin, 5-FU, leucovorin, tigio capsules and teriprizumab. Dosage and dosing regimen for all research phases: The enrolled patients will receive 4 cycles of FLOT regimen + teriprizumab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). The specific plan is as follows. 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 If the transformation is successful, the patient undergoes R0 surgical resection of D2 lymph node dissection for gastric cancer in accordance with the "Japanese Gastric Cancer Treatment Guidelines. Physician's Edition. 4th Edition". After the operation, the patient will continue to receive 4 cycles of FLOT treatment + Teripril Anti-treatment, the treatment plan is the same as before. After completing the 4 cycles of treatment, oral Tiggio Capsule (S-1) and Teriprizumab were maintained for 1 year. The specific plan is as follows. 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.

6. Conditions and Keywords

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

Chemotherapy, Gastric Cancer

Keywords

FLOT, PD-1, Gastric cancer, Peritoneal metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FLOT combined with PD-1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Surgical conversion rate

Description

defined as the proportion of patients who have undergone R0 surgical resection after multidisciplinary assessment after completing 4 courses of conversion adjuvant therapy

Time Frame

2-3 months

Title

TRG grade

Description

tumor regression grade

Time Frame

2-3 months

Secondary Outcome Measure Information:

Title

PFS

Description

Progression-free survival

Time Frame

1 year

Title

Description

overall survival

Time Frame

1 year

Title

the incidence and severity of adverse events

Description

the incidence and severity of adverse events

Time Frame

1 year

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: Informed consent of the patient; 18 years old <age <80 years old; The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathology (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por); The clinical stage of laparoscopic exploration is peritoneal metastasis, peritoneal nodule pathologically confirmed metastasis and/or exfoliated cytology test positive for advanced gastric cancer patients; Preoperative ECOG [Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)] Physical State Score 0/1; Preoperative anesthesia risk score sheet (ASA score sheet) I-III; Exclusion Criteria: The pathology of the peritoneal nodule confirmed no metastasis, and the exfoliated cytology test was negative; Pregnant or lactating women; Suffer from severe mental illness; Preoperative imaging or intraoperative exploration revealed that there have been distant blood metastases in the liver, lungs, and brain; A history of other malignant diseases within 5 years; A history of allergies to any component of teriprizumab, docetaxel, oxaliplatin, and fluorouracil; A history of continuous systemic corticosteroid therapy within 1 month; Complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery; A history of unstable angina or myocardial infarction, or a history of cerebral infarction or cerebral hemorrhage within 6 months, and a lung function test FEV1 <50% of the expected value; Have received any of the following treatments: Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past; Have received any investigational drug treatment within 4 weeks before using the drug for the first time; Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug; Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time.

Facility Information:

Facility Name

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact: