NCT04989985

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Gastroesophageal Junction Adenocarcinoma
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Oxaliplatin+S-1	Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w Drug: S-1 S-1: 40\~60mg Bid，d1\~14, q3w
DRUG	Sinitilimab+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

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-08-01
• Completion: 2027-08-01
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: China