Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Antibodies

Antibodies, Monoclonal

Docetaxel

Fluorouracil

Oxaliplatin

Calcium

Immunoglobulins

Calcium, Dietary

Immunologic Factors

Oxaliplatin#80mg/m2d1#iv infusion for 2 hours# Calcium leucovate#200mg/m2d1#iv infusion# Fluorouracil#2600mg/m2,intravenous drip for 24h# Docetaxel#50mg/m2,intravenous drip for 1 h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

PD-1 Monoclonal Antibody(Sintilimab)

Jing Ding, MD

Ning Li, PhD

Ning LI, PhD

Ning Li, Phd

This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocarcinoma.

Into a set of 25 cases of the gastric carcinoma confirmed by pathology or gastroesophageal junction adenocarcinoma (cT4 and/or N + M0, Multi-Disciplinary Team thought line to perioperative treatment) patients, preoperative accept four cycle by bead a resistance + sintilimab + capecitabine plus oxaliplatin into new adjuvant chemotherapy, because PD1 antibodies distance between surgery time interval is the lack of clinical data, judging by the researchers is 4 cycles of chemotherapy combination of sintilimab .The patient was able to undergo D2 radical surgery.Pathological examination was carried out to observe the pCR and the infiltration rate of immune cells.After the operation, patients continued to receive 4 cycles of capecitabine + oxaliplatin adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.Disease-free survival time and safety of treatment were observed, and OS, ORR and quality of life of all patients were followed up.

PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

Phase II Clinical Study of PD-1 Monoclonal Antibody (Sintilimab) Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma/ Esophagogastric Junction Adenocarcinoma

Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the surgical specimens (see WHO solid tumor efficacy criteria

The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. Patients with new non-breast cancer malignancy must continue to be followed for progression of the original breast cancer. For patients without progression, follow-up is censored at the date of last disease assessment without progression, unless death occurs within 12 weeks following the date last known progression-free, in which case the death will be counted as a DFS event.

Henan Cancer Hospital

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Recurrence

Stomach Neoplasms

Disease Attributes

Stomach Cancer

Nivolumab

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).

Treatment: Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year. No chemotherapy.

Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year

Nivolumab and Ipilimumab

chemotherapy

Florian Lordick

Maren Knoedler

Elizabeth Smyth

The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.

Other study objectives:

* To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study
* To correlate nutritional status assessment on outcomes and quality of life of patients

Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence

Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study

Disease free survival is defined as the time interval between randomization and the date of disease recurrence or death from any cause, whichever comes first. Patients alive with no disease recurrence are censored at the date of the last follow-up examination. randomization and the date of disease recurrence or death from any cause, whichever comes first.

Overall survival is defined as the time interval between the date of randomization and the date of death from any cause. Patients who are still alive when last traced are censored at the date of last follow up.

Local recurrence is defined as evidence of tumor in the anastomotic area. Regional recurrence is defined as evidence of tumor in the locoregional lymph nodes or other surrounding structures apart from the anastomotic site. Death in absence of loco-regional failure will be considered as a competing risk in the estimation of the cumulative incidence of loco-regional failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination.

The diagnosis of distant recurrence requires imaging confirmed by pathology. Once recurrence is confirmed, the date of recurrence is the first date when recurrence was suspected.

Distant recurrence is defined as recurrence not considered as local or regional.Death in absence of distant failure will be considered as a competing risk in the estimation of the cumulative incidence of distant failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination

All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events. AEs will be collected at baseline from randomization.

Only the worst grade per CTCAE category will be recorded per cycle. All adverse events must be followed until resolution or stabilization. Adverse Events of Special Interest for ipilimumab and nivolumab requiring a close follow-up were identified as a result of signals observed from previous studies involving the protocol treatments. These events require a close follow-up

Quality of life will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom (fatigue, nausea and vomiting and pain) and a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). The primary HRQoL endpoints that are considered relevant for this study are global health status/QoL and physical functioning.A difference of 10 points on the 100-point QLQ-C30 scale between the two arms will be considered as clinically relevant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma	NCT04341857	Gastric and Eso...	PD-1 Monoclonal...	18 Years - 75 Years	Henan Cancer Hospital
Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence	NCT03443856	Gastric and Eso...	Nivolumab and I... chemotherapy	-	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for gastric and esophagogastric junction adenocarcinoma