Status:
RECRUITING
Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer
Lead Sponsor:
Huashan Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) in resectable locally advanced gastric cancer.
Detailed Description
This is a single-arm clinical study to enroll 50 patients with gastric cancer (cTNM diagnosis of cT3-4aN1-3M0). Each enrolled patient will be assigned a case number. Both this case number and the pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06054906
Start Date
October 18 2023
End Date
December 31 2025
Last Update
December 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Huashan Hospital, Fudan University
Shanghai, China