Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer : a Phase Il Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: sintilimab+metronomic PLOF
sintilimab therapy(200mg, iv,d1,Q3W, 2cycles)and PLOF chemotherapy (Paclitaxel 60 mg/m2, oxaliplatin 50 mg/m2, 5-fluorouracil 425mg/m2, d1, QW, 6cycles) followed by adjuvant sintilimab therapy(200mg, iv,d1,Q3W, 2cycles)and PLOF chemotherapy (Paclitaxel 60 mg/m2, oxaliplatin 50 mg/m2, 5-fluorouracil 425mg/m2, d1, QW, 6cycles) neoadjuvant chemotherapy (8 weeks) preceding surgery (3 weeks after completion of chemotherapy) followed by adjuvant chemotherapy (16 weeks, begin within 12 weeks after surgery)
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov