Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer

NCT05982301 | Unknown Phase 2 DMC

• 1 other identifier: FDZL-PFMG
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. To compare the time of maintenance of treatment after induction of chemotherapy with sintilimab combined with modified FLOT regimen until the reapplication of induction regimen with or without the combination of sintilimab, and the time of secondary progression after signing informed consent until the reapplication of induction regimen with or without the combination of sintilimab.

Conditions

Gastric Cancer; Chemotherapy Effect; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression-Free survival 2, PFS2

  From date of informed consent to time of secondary progression

  From date of informed consent to time of secondary progression, assessed up to 60 months

Secondary Outcomes (4)

• Overall survival, OS

  the period from the date of randomization to the date of death from any cause, assessed up to 60 months

• Objective response rate

  Baseline, Every 6 weeks during the procedure, up to 1 year. After 1 year, every 3 months.

• Progression-Free survival 1, PFS1

  From date of informed consent to time of first progression, assessed up to 60 months.

• After Effects

  Baseline, Every cycle of treatment, until disease progression or death, whichever come first.

Study Arms (1)

Nab-POF

EXPERIMENTAL

Sintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w.

Drug: Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU

Interventions

Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU DRUG

The study has only one arm. Sintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w.

Also known as: Sintilimab+mFLOT

Nab-POF

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years and men or women
• With histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, local lesions that cannot be radically resected, or metastatic gastric cancer
• For treatment-naïve patients, or postoperative recurrence at least 6 months from the last adjuvant chemotherapy
• With Eastern Cooperative Oncology Group (ECOG) PS of 0-1
• With a life expectancy of more than 3 months
• Who obtain the following laboratory test data within 7 days (including the seventh day) prior to the study screening: neutrophil count of ≥1.5 × 10\^9/L, platelet count of ≥100 × 10\^9/L, hemoglobin level of ≥90 g/L, serum total bilirubin of ≤1.25 the upper limit of normal (ULN); ALT and AST levels of ≤2.5 × ULN (≤5 × ULN for patients with liver metastasis); serum creatinine level of ≤1.0 × ULN and creatinine clearance of ≥50 ml/min; International Normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; If the subject is receiving anticoagulant therapy, PT should be within the prescribed anticoagulant range.
• With at least one extragastric measurable lesion (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria)
• Patients (or their legal representative/guardian) must sign an informed consent form indicating that they understand the purpose of the study, understand the procedures necessary for the study, and are willing to participate in the study.

You may not qualify if:

• Patients with history of other types of cancer in the last 3 years, except for cured cervical cancer or cutaneous basal cell carcinoma.
• Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for \>2 months) who has a negative imaging result within 4 weeks before participating in the study and is stable disease at study entry.
• Patients with clinically significant gastrointestinal obstruction, gastrointestinal bleeding (defecate occult blood + + + and above) or perforation.
• Patients who have received PD-1, PD-L1 or PD- L2, CD137, CTLA-4 antibody therapy, or any other T cells stimulate or total checkpoint pathways for specific target antibody or drugs.
• Patients with active, or have a history and possible recurrence of autoimmune disease of the subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as those who have received an organ transplant requiring immunosuppressive therapy). However, patients with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment within the last 2 years, or patients with hypothyroidism who required only thyroid hormone replacement therapy, and patients with type 1 diabetes who required only insulin replacement therapy could be enrolled.
• Patients now with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung diseases, radiation pneumonia.
• Patients who received any investigational drugs or antitumor drugs within 4 weeks prior to enrollment.
• Patients who received immunosuppressive drugs within 4 weeks, which does not include nasal, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/ day of prednisone or equivalent doses of other corticosteroids), or short-term (not exceeding 7 days) use of corticosteroids for the prevention or treatment of non-autoimmune allergic diseases.
• Patients who received the live attenuated vaccine within 4 weeks before the first dose of study treatment. Note: Inactivated virus vaccines for injectable seasonal influenza are permitted for up to 4 weeks prior to initial administration; But live attenuated influenza vaccines are not allowed;
• Patients who received major surgery within 4 weeks before the first dose of study treatment(open chest, craniotomy or laparotomy) or expected during the research and treatment need to accept major surgery not associated with this study.
• Patients who infected with human immunodeficiency virus (HIV) disease (HIV antibody positive), or with other acquired, congenital immunodeficiency disease, or has a history of organ transplantation, or stem cell transplantation.
• Patients who have chronic active hepatitis B or active active hepatitis C. Hepatitis B virus carriers, stable after drug treatment of hepatitis B (DNA drop degree is not higher than 200 iu/mL or copy number \< 1000 copies/mL) and has cured patients with hepatitis c (HCV RNA test negative) into the group.
• Patients with known active tuberculosis.
• Patients with severe infections before 4 weeks of fisrt dose of treatment, active infection which needs oral or intravenous antibiotic therapy before 4 weeks of fisrt dose of treatment.
• Patients with symptomatic congestive heart failure (New York heart association grade II - IV) or symptomatic or poorly controlled arrhythmia.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• WeiJian Guo, M.D.,Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WeiJian Guo, M.D.,Ph.D.

CONTACT

64175590; guoweijian1@hotmail.com

XiaoDong Zhu, M.D.,Ph.D.

CONTACT

64175590; xddr001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Gastrointestinal Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: August 8, 2023
• Study Start: February 9, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We plan to share IPD after the publication of the study.
• Access Criteria: Data sharing requires approval from the principal investigator.

Locations

CN (1)