Neoplasms

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Digestive System Diseases

Rare Diseases

Adenocarcinoma

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

SOX: Oxaliplatin+S-1

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;

S-1:40\~60mg Bid, d1\~14, q3w;

Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 4-6 cycles.

Sinitlimab + SOX； SOX: Oxaliplatin+S-1

Sinitlimab: 200mg, ivdrip, d1, q3w;

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;

S-1:40\~60mg Bid, d1\~14, q3w;

Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 4-6 cycles.

Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w

Drug: S-1 S-1: 40\~60mg Bid，d1\~14, q3w

Oxaliplatin+S-1

Drug: Sintilimab Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip, d1, q3w.

Other Name: PD-1 antibody

Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w

Drug: S-1 S-1: 40\~60mg Bid，d1\~14, q3w

Sinitilimab+oxaliplatin+S-1

Jun-Sheng Peng

Shi Chen

Jun-Sheng Peng, Dr

Yan-Hong Deng, Dr

For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.

Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China. Unfortunately, over 70% of gastric cancer patients in China were diagnosed in advanced stage, and more than 80% of adenocarcinoma of esophagogastric junction(AEG) were advanced stage. Locally advanced AEG (cT3-4aN+M0) could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. As proved, Neoadjuvant chemotherapy can downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival in AEG patients. However, the therapeutic effects remain unsatisfactory. PD-1 antibody has demonstrated its efficacy in metastatic AEG and has been proved to be effective in neoadjuvant setting in lung cancer and melanoma. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sinitilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for lymphoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sinitilimab in combination with perioperative chemotherapy（SOX: oxaliplatin plus S-1） in locally advanced AEG.

S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma

Perioperative SOX Plus Sintilimab Compared With Perioperative SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: an Open-label, Phase 2 Randomised Controlled Trial

Rate of microscopically margin-negative resection

the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented recurrence

The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma	NCT04989985	Locally Advance... Chemotherapy Ef...	Oxaliplatin+S-1 Sinitilimab+oxa...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma	NCT04989985	Locally Advance... Chemotherapy Ef...	Oxaliplatin+S-1 Sinitilimab+oxa...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University

Spots Global Cancer Trial Database for sinitilimab

Every month we try and update this database with for sinitilimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sinitilimab

Every month we try and update this database with for sinitilimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sinitilimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.