An Open, Single-center, Phase II Clinical Trial Evaluating the Efficacy of PD-1 Antibody (JS001) in Combination With Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

Who is this study for? Patients with Gastric Cancer
What treatments are being studied? Toripalimab Injection
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the prognosis is poor. Previous studies have shown that patients with pathological complete response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT (5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer. Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rate(ORR) as compared to chemotherapy alone in advanced gastric cancer. The nanoparticle albumin-bound paclitaxel has been recommended as the second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese Society of Clinical Oncology(CSCO) guideline. When PD-1 antibody is applied, albumin-bound paclitaxel is considered as a better partner since no pretreatment of corticosteroids is needed. Thus, the investigators plan to conduct a phase II clinical trial to evaluate the efficacy and safety of toripalimab (PD-1 antibody) combined with the FLOAP (albumin-bound paclitaxel, oxaliplatin, fluorouracil and leucovorin) regimen as the perioperative treatment of cT2-4 and/or N+ GC. The primary end point is pCR rate. The secondary end points include disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Age ≥18 yeas and ≤79 years. The gender is not limited.

• Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.

• Endoscopic ultrasonography and/or enhanced CT/MRI examination confirmed at the stage of cT3/4a Nx or T2 N1-3, M0(AJCC 8th) before randomization.

• At least 15 unstained sections of formalin-fixed paraffin-embedded tumor tissue sections or fresh tumor tissues can be provided for PD-L1, TMB, tumor infiltrating T lymphocytes, MSI-H/dMMR and EBV detection.

• The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1

• Adequate bone marrow and organ function meets the following criteria:

‣ Neutrophil count (ANC)≥1.5×l09/L

⁃ Platelet (PLT) ≥80×109/L

⁃ Hemoglobin (Hb) level ≥9.0 g/L

⁃ Total bilirubin level≤1.5×ULN

⁃ Alanine aminotransferase (ALT) level≤3×ULN

⁃ Aspartate aminotransferase (AST) level ≤3×ULN

⁃ International normalized value (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN

⁃ Serum creatinine (Cr) level ≤1.5×ULN

⁃ Creatinine clearance \>50 ml/min (Calculated according to the Cockcroft-Gault formula)

Locations
Other Locations
China
Shenzhen People's Hospital
RECRUITING
Shenzhen
Shenzhen People's Hospital
RECRUITING
Shenzhen
Contact Information
Primary
Wan He, PhD
hewanshenzhen@hotmail.com
+8618823719462
Backup
Wenwen Li, PhD
wenwenlee@live.cn
+8622948111
Time Frame
Start Date: 2021-09-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 62
Treatments
Experimental: Toripalimab group
Toripalimab is administrated with160mg and repeated every 2 weeks.
Related Therapeutic Areas
Sponsors
Leads: Wan He

This content was sourced from clinicaltrials.gov

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