Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer

Официальное название

The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer

Обзор

The goal of this observational study is to analyze the impact of different durations of neoadjuvant PD-1 inhibitor combined with chemotherapy on tumor regression and safety in patients with advanced gastric cancer. The main questions it aims to answer are: * Does the duration of neoadjuvant treatment influence tumor regression grading (TRG)? * How does treatment duration affect perioperative safety and clinical outcomes? Participants who have previously undergone neoadjuvant PD-1 inhibitor combined with chemotherapy followed by surgery as part of their routine medical care will have their clinical data retrospectively reviewed and analyzed.

Вмешательства

• Препарат ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
  Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no more than 4 cycles
• Препарат ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
  Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no less than 5 cycles
• Процедура Gastrectomy
  Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed

Первичные конечные точки

• Tumor Regression Grading (TRG) [Срок оценки: Approximately 1 week after surgery (when the pathology examination report available)]

Вторичные конечные точки (8)

• Safety [Срок оценки: From the start of neoadjuvant chemotherapy to 7 days after surgery]
• R0 resection [Срок оценки: Approximately 1 week after surgery (when the pathology examination report available)]
• Operative time [Срок оценки: On the day of the surgery (can be obtained immediately after the completion of the surgery)]
• Time to first flatus [Срок оценки: From date of surgery until the date of first flatus, assessed up to 10 days post-surgery]
• Nutritional Risk Screening 2002 (NRS 2002) [Срок оценки: Approximately 1 week after completing all neoadjuvant therapy]
• YpTNM staging [Срок оценки: Approximately 1 week after surgery (when the pathology examination report available)]
• Dissected lymph node number [Срок оценки: Approximately 1 week after surgery (when the pathology examination report available)]
• Positive lymph node number [Срок оценки: Approximately 1 week after surgery (when the pathology examination report available)]

Критерии участия

Критерии включения

• Non-bedridden patients aged 18-90 years;
• Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy;
• Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration;
• No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy;
• No history of other malignancies within the past 5 years;
• Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents;
• Underwent radical gastrectomy after neoadjuvant therapy;
• No severe underlying diseases.

Критерии исключения

• Incomplete or inaccessible clinical and pathological data;
• Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma;
• Distant metastases present prior to treatment;
• Concurrent diagnosis of other malignancies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

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• Sun W, Veeramachaneni N, Al-Rajabi R, Madan R, Kasi A, Al-Kasspooles M, Baranda J, Saeed A, Phadnis MA, Godwin AK, Olyaee M, Streeter N, Nagji A, Dai J, Williamson S. A phase II study of perioperative pembrolizumab plus mFOLFOX in patients with potentially resectable esophagus, gastroesophageal junction (GEJ), and stomach adenocarcinoma. Cancer Med. 2023 Aug;12(15):16098-16107. doi: 10.1002/cam4.6 PMID 37326317
• Yuan SQ, Nie RC, Jin Y, Liang CC, Li YF, Jian R, Sun XW, Chen YB, Guan WL, Wang ZX, Qiu HB, Wang W, Chen S, Zhang DS, Ling YH, Xi SY, Cai MY, Huang CY, Yang QX, Liu ZM, Guan YX, Chen YM, Li JB, Tang XW, Peng JS, Zhou ZW, Xu RH, Wang F. Perioperative toripalimab and chemotherapy in locally advanced gastric or gastro-esophageal junction cancer: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):552 PMID 38167937
• Raimondi A, Lonardi S, Murgioni S, Cardellino GG, Tamberi S, Strippoli A, Palermo F, De Manzoni G, Bencivenga M, Bittoni A, Chiodoni C, Lorenzini D, Todoerti K, Manca P, Sangaletti S, Prisciandaro M, Randon G, Nichetti F, Bergamo F, Brich S, Belfiore A, Bertolotti A, Stetco D, Guidi A, Torelli T, Vingiani A, Joshi RP, Khoshdeli M, Beaubier N, Stumpe MC, Nappo F, Leone AG, Pircher CC, Leoncini G, S PMID 39637944
• Andre T, Tougeron D, Piessen G, de la Fouchardiere C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lievre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenoca PMID 35969830
• Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phas PMID 37875143

Идентификаторы

NCT: NCT06798376 · S2024-823

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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