Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable… (NCT06684158) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC
China70 participantsStarted 2024-11-30
Plain-language summary
This study is a prospective, randomized ,multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)) as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.Subjects aged 18-75 years (including 18 and 75 years old);
* 2.Subjects who understand the study procedures and content, and voluntarily sign the written informed consent form;
* 3.Subjects with HER2-negative or HER2 status unknown gastric or gastroesophageal junction adenocarcinoma, clinically staged as T3-4a/N+M0 locally advanced gastric cancer by ultrasound gastroscopy, CT/MRI and other imaging evaluations.
* 4.Subjects who have not received prior systemic therapy.
* 5.Subjects with Eastern Cooperative Oncology Group Performance Status score (ECOG PS score): 0-1;
* 6.Subjects with life expectancy ≥ 12 months;
* 7.Subjects with good major organ function, that is, the relevant investigation indicators within 14 days before enrollment meet the following requirements: haemoglobin ≥ 90 g/L ; neutrophil count \> 1.5 × 109/L; platelet count ≥ 100 × 109/L; total bilirubin ≤ 1.5 × ULN (upper limit of normal); alanine transaminase (ALT) or aspartate transaminases (AST) ≤ 2.5 × ULN; endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); cardiac ultrasound doppler assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
* 8.Subjects with thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) within the normal range or with slight and clinically insignificant abnormalities;
* 9.Subjects weighing more than 40 kg, or with BMI \> 18.5;
Exclusion Criteria:
* 1.Subjects with a history of or concurrent with othe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic Complete Response (pCR)
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT06684158
SponsorThe First Affiliated Hospital with Nanjing Medical University