Safety and Efficacy of Pembrolizumab in Combination With FLOT About Gastroesophageal Junction Cancer:

NCT06411171 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY20232301-F-1
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

At present, surgery is still the main treatment for gastroesophageal junction cancer. At the same time, multimodal comprehensive treatment such as chemotherapy and molecular targeted therapy can effectively alleviate pathological progression, facilitate R0 resection and improve the overall survival of patients.Pembrolizumab, as a PD-1 inhibitor, has been shown to have antitumor activity and a manageable safety profile in gastroesophageal junction cancer.Pembrolizumab combined with chemotherapy has become a research hotspot. However, to date, there is no clinical study related to gastroesophageal junction cancer. In this study, Pembrolizumab combined with FLOT was used as the first-line treatment for gastroesophageal junction cancer, aiming to explore the experience chemotherapy mode for gastroesophageal junction cancer.

Conditions

Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  objective response rate

  3 year

Secondary Outcomes (4)

• duration of response

  1 year

• disease control rate

  1 year

• time to response

  1 year

• overall surival

  5 year

Study Arms (2)

Pembrolizumab plus chemotherapy (FLOT)

EXPERIMENTAL

Pembrolizumab plus chemotherapy (FLOT)

Drug: Pembrolizumab plus chemotherapy (FLOT)

chemotherapy (FLOT)

ACTIVE COMPARATOR

chemotherapy (FLOT)

Drug: Pembrolizumab plus chemotherapy (FLOT)

Interventions

Pembrolizumab plus chemotherapy (FLOT) DRUG

The experimental group was treated with pembrolizumab combined with FLOT, and the control group was treated with FLOT chemotherapy alone

Also known as: docetaxel, oxaliplatin, fluorouracil, and leucovorin (the FLOT regimen)

Pembrolizumab plus chemotherapy (FLOT); chemotherapy (FLOT)

Eligibility Criteria

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

You may qualify if:

• \) aged from 18 to 75 years old, including 18 and 80 years old;
• \) histologically or cytologically confirmed locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma;
• \) ECOG PS score 0 or 1;
• \) Known PD-L1 expression (assessed centrally using PD-L1 HC22C3)
• \) no previous treatment
• \) HER2-negative status
• \) normal hematological parameters: white blood cell count ≥4×109/L; Absolute neutrophil count ≥1.5×109/L; Platelet count ≥100×109/L; Blood red protein g/L;
• \) basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl)\> 60 mL/min(using Cockcroft-Gault formula):
• Female CrCl=(140-age)× weight (kg)× 0.85 / (72×Scr mg/dl)
• Male CrCl=(140-age)× weight (kg)× 1.00 / (72×Scr mg/dl)
• Liver function was basically normal: serum total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) ≤2.5×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN.
• Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients)
• \) Provide written informed consent. Written informed consent was obtained.

You may not qualify if:

• \) receiving anti-tumor therapy before enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-Tkis, and anti-angiogenic drugs;
• \) A history of autoimmune disease, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Patients with vitiligo, type I diabetes, or residual hypothyroidism due to autoimmune conditions (e.g., after Hashimoto's syndrome) requiring only hormone-replacement therapy, psoriasis requiring no systemic therapy, or if recurrence was not expected in the absence of an external trigger were allowed.) ;
• \) participated in other interventional clinical trials within 30 days before screening;
• \) Patients with a history of other malignant tumors (except cured basal cell carcinoma)
• \) with severe uncontrolled comorbidities (e.g., heart failure, diabetes mellitus, hypertension, liver failure, renal failure, thyroid disease, mental illness, etc.);
• \) known HIV infection or active viral hepatitis or tuberculosis;
• \) have a major surgical procedure or planned surgery within 30 days before the first dose of the trial drug;
• \) patients who are allergic to the drugs used in this regimen or their components;
• \) pregnant (confirmed by blood or urine HCG testing) or lactating women, or childbearing age subjects unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
• \) The investigator considers that it is not appropriate to participate in the study;
• \) unwilling to participate in the study or unable to sign an informed consent form

Sponsors & Collaborators

• xiaohua li: lead

MeSH Terms

Interventions

pembrolizumab; Drug Therapy; Docetaxel; Oxaliplatin; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 17, 2024

Record last verified: 2024-05