Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer

Recruiting now · Phase 2

Conditions studied: Gastric Cancer

In brief

To evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) in resectable locally advanced gastric cancer.

Key facts

Study ID: NCT06054906
Run by: Huashan Hospital
People needed: 50
Starts: 2023-10-18
Expected to finish: 2025-12-31
Last updated by the study team: 2024-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed written Informed Consent Form
Male or female, age ≥ 18 years old
Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator
No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand
Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon
ECOG PS: 0-1 score
Expected survival > 6 months
Adequate organ function, must meet the following laboratory specifications:
1 Absolute neutrophil count (ANC) ≥ 1.0x10\^9/L; 8.2 Platelets ≥ 80x10\^9/L; 8.3 Hemoglobin > 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Total bilirubin > 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); 8.5 AST, ALT ≤ 2.5×ULN; 8.6 Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min; 8.7 INR or PT ≤ 1.5 times ULN; 8.8 TSH within normal range (Enrollment allowed if baseline TSH is outside normal range but FT4 is within normal range); 8.9 Myocardial enzyme profile within normal range;
Negative pregnancy test in women of childbearing age
Need to use contraception with an annual failure rate of less than 1% if there is a risk of conception

You may not qualify if…

Endoscopically show signs of active bleeding from the lesion
Current participation in an interventional clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc.
Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy
Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug
Live vaccination within 30 days prior to the first administration of the drug
Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug
Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment
Has not fully recovered from any intervention-induced toxicity and/or complications (excluding malaise or alopecia) prior to initiation of therapy
Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
Known hypersensitivity to drugs used in this study
Known history of HIV infection
Untreated active hepatitis B
Active HCV infection
Pregnant or lactating women
The presence of any serious or uncontrolled systemic disease
Other factors that, in the judgment of the investigator, may affect the outcome of the study

Where it is running

Huashan Hospital, Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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