A Multi-center, Two-arm, Phase 2 Clinical Study on the Perioperative Treatment of HER2-positive Resectable Esophagogastric Junctional Adenocarcinoma With Nabulimab Combined With FLOT and Trastuzumab VS FLOT Combined With Trastuzumab
Adenocarcinoma of the Esophagogastric JunctionPerioperative Period
Investigational drug(s) / intervention(s)
The experimental group received Nivolumab
The experimental group received Nivolumab: Trastuzumab and the FLOT chemotherapy regimen are clearly recommended by guidelines, whereas Nivolumab is currently requiring further research validation.
Study summary
Patients with Her2+ resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuzumab. 4 cycles were performed before and after surgery in both groups, with one cycle every 2 weeks. The specific administration was docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). Surgical treatment was evaluated by the investigator within 3-4 weeks after the last dosing. After 4 cycles of adjuvant therapy, the observation group received nebuliumab combined with trastuzumab, while the control group received maintenance therapy with trastuzumab. Both groups received 10 cycles, one cycle every 2 weeks. The specific administration was as follows: nebuliuzumab 240mg iv,d1, 30 minutes per intravenous infusion; Trastuzumab 4mg/kg intravenously.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years old;
2. esophagogastric junction adenocarcinoma (including Siewert type I, Siewert type II, and Siewert type III) with histopathologic or cytological confirmation of HER2-positive (defined as positive immunohistochemical \[IHC\] greater than or equal to 2+ and fluorescence in situ hybridization \[FISH\]);
3. The cTNM stages were cT3-4a, N+, M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary) (refer to the 8th edition AJCCTNM staging system), and the lesions were resected as assessed by the investigator;
4. Expected survival time \> 6 months;
5. ECOG PS score 0 or 1;
6. PD-L1 does not require;
7. No prior treatment;
8. Hematological indexes were basically normal: white blood cell count ≥4×109/L; Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥ 90 g/Lg/L;
9. Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl)\>60 mL/min(using the Cockcroft-Gault formula);
10. Basically normal liver function: serum total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) ≤2.5×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN;
11. Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients)
12. Sign written informed consent.
Exclusion Criteria:
* (1) No efficacy and/or safety evaluation has been performed; (2) The investigator believes that the patient is not suitable to continue (reasons for withdrawal should be recorded) (3) The patient requested that the trial be terminated; (4) Serious violation of protocol: participating in this study while using other anti-tumor drugs and/or modern Chinese medicine preparations with anti-cancer indications.
Primary outcome measure(s)
Pathological complete response rate (pCR) — 30 days Pathological complete response rate refers to the proportion of primary tumor sites and surgical specimens with no viable tumor cells (ypT0N0) in all resected lymph nodes to the total number of patients evaluated centrally by the study pathologist
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of the Air Force Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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