This is a single-institution, prospective phase II trial designed to evaluate the efficacy of neoadjuvant chemotherapy and sequential immunotherapy in patients with locally advanced esophagogastric junction and gastric adenocarcinoma. Patients with Her-2 positive or dMMR tumors will be excluded from the study. Six cycles of nab-paclitaxel, oxaliplatin and S-1 with or without bevacizumab, followed by three circles of nab-paclitaxel, bevacizumab, with or without S-1 combined with two cycles of PD-1 monoclonal antibody, will be administered as neoadjuvant therapy. Patients will receive different adjuvant treatments depending on the degrees of surgical radicality and the pathological reactions of tumors.
Study Type
OBSERVATIONAL
Enrollment
70
Drug: Paclitaxel(albumin-bound) 130mg/m2, ivgtt, D1, Q2w Drug: Oxaliplatin 70 mg/m2, ivgtt, D1, q2w Drug: S-1 40mg (body surface area \< 1.25m2), bid, D1-8, Q2w 50mg (body surface area \>1.25m2, \<1.5 m2), bid, D1-8, Q2w 60mg (body surface area \>1.5m2), bid, D1-8, Q2w Drug: Bevacizumab, 5mg/kg, ivgtt, D1, Q14d Drug: PD-1 antibody, 200mg, ivgtt, D1, Q21d Patients with Her-2 negative, MMR-proficient locally advanced esophagogastric junction or gastric adenocarcinoma will receive 6 cycles of neoadjuvant chemotherapy with or without antiangiogenesis. After comprehensive evaluations, patients who respond to chemotherapy will further receive 2 cycles of PD-1 antibody comibed with antiangiogenesis and chemotherapy as neoadjuvant therapy. Drug: Pembrolizumab or sintilimab, 100\~200mg, ivgtt, D1, Q3w. Patients will make the final decision of PD -1 antibody according to their economic condition.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China
Event-free survival (EFS)
The time from recruitment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause.
Time frame: From the recruitment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Major pathological response
It is defined as residual tumors less than 10% after neoadjuvant systemic therapy according to Mandard grade.
Time frame: From the date of recruitment to 3 months after all treatment ends
Overall survival(OS)
The time from recruitment to the date of death for any reason or the date of last follow-up
Time frame: From the date of recruitment to the date of death from any cause or the date of last follow-up, assessed up to 36 months
R0 resection rate
Rate of microscopically margin-negative resection
Time frame: From the date of recruitment to 3 months after all treatment ends
Adverse events
Adverse events (AEs) of neoadjuvant and adjuvant systemic therapy will be graded and documented according to NCI-CTCAE v5.0 and immune-related Adverse Event, irAE from the beginning of treatment to 3 months since the last dosage of treatment. Documentary will include severity, lasting period and occurrence time. Surgery complications will also be documented.
Time frame: From the date of recruitment to 3 months after all treatment ends
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