NCT04694183

The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

PD-1 Inhibitor Plus Chemotherapy as Conversion Therapy in Unresectable Gastric Cancer (STARS-GC01): A Single-arm, Single-center, Prospective Clinical Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Quan Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined with immunotherapy. At the same time as the primary cancerous lesions are reduced, the distant metastatic lesions are effectively controlled in order to perform R0 surgery and to improve the survival rate of patients with advanced gastric cancer.

Detailed description

The interventions include camrelizumab and chemotherapy selected based on the use of different metastatic sites as conversion therapy.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg, intravenous drip administration, d1, every 3 weeks.
DRUG	S-1	Oral, d1-14, every 3 weeks.
DRUG	Oxaliplatin	130mg/m² intravenous drip administration, d1, every 3 weeks(For patients with liver and/or para-aortic lymph node metastasis).
DRUG	Paclitaxel	Intraperitoneal paclitaxel 20 mg/m² and intravenous paclitaxel 50 mg/m² on days 1 and 8, every 3 weeks(For patients with peritoneal metastasis ).

Timeline

• Start date: 2020-08-17
• Primary completion: 2023-05-06
• Completion: 2023-05-06
• First posted: 2021-01-05
• Last updated: 2024-02-07

Locations

1 site across 1 country: China