PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

NCT04341857 | Unknown Phase 2

• 1 other identifier: HN20190929
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocarcinoma.

Conditions

Gastric and Esophagogastric Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the surgical specimens (see WHO solid tumor efficacy criteria

  immediately after surgery

Secondary Outcomes (1)

• Disease free survival(DFS)

  From the date of first treatment dose until documented disease progression or death from any cause. whichever occur first, assessed up to 30 months

Study Arms (1)

Sintilimab combined with FLOT regimen

EXPERIMENTAL

Oxaliplatin#80mg/m2d1#iv infusion for 2 hours# Calcium leucovate#200mg/m2d1#iv infusion# Fluorouracil#2600mg/m2,intravenous drip for 24h# Docetaxel#50mg/m2,intravenous drip for 1 h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Drug: PD-1 Monoclonal Antibody(Sintilimab)

Interventions

PD-1 Monoclonal Antibody(Sintilimab) DRUG

Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Sintilimab combined with FLOT regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed;
• Only patients aged 18-75 were enrolled;
• Pathologically confirmed gastric adenocarcinoma (cT4 or/and N+M0, MDT considers perioperative treatment necessary) :Bone scan should be performed if bone metastasis is suspected.If peritoneal metastasis is suspected, laparoscopy should be performed;
• No previous cytotoxic chemotherapy or targeted therapy;
• No previous local resection of the tumor;
• ECOG 1 or less;
• Tumor specimens capable of detecting PDL-1 and MSI status are available.The detection of PDL-1 and MSI will be conducted after random grouping.This test requires the patient to provide a paraffin-embedded biopsy specimen;
• Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without transfusion, absolute value of neutrophils (ANC) without granulocyte stimulation factor ≥ 1.5×109/L, and hemoglobin≥ 90 g/L;
• Bilirubin ≤ 1.5 times of the upper limit of normal value, and rice grass and rice propyl transaminase ≤ 2.5 times of the upper limit of normal value;
• Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45ml/min;
• Serum albumin ≥ 25g /L (2.5g /dL);
• INR or aPTT ≤1.5 times ULN;

You may not qualify if:

• Allergy to any experimental drug and its excipients, or a history of severe allergy, or a contraindication to the experimental drug;
• Ahistory of autoimmune diseases or active stage;
• Previous allogeneic bone marrow transplantation or organ transplantation;
• Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia;
• HIV test positive;
• Active hepatitis b or c;
• Active tuberculosis;
• Uncontrolled cancer pain;
• Live attenuated vaccine was injected within 4 weeks before the study began, or live attenuated vaccine was expected to be injected during the trial or within 5 months after the trial;
• Previous immunotherapy, including CTLA4, anti-pd-1, or anti-pdl1 monoclonal antibody;
• CT suggested active pulmonary inflammation;
• Systemic application of glucocorticoids or immunosuppressants within 2 weeks before the start of the trial.Inhaled glucocorticoids and glucocorticoids are allowed;
• There are taboos on hormone use;
• Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the trial;
• Uncontrolled increase in blood pressure or blood sugar;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Study Officials

• Ning Li, Phd

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ding, MD

CONTACT

13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 10, 2020
• Study Start: July 30, 2019
• Primary Completion: May 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CN (1)