Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction

NCT05918419 | Unknown Phase 2

• 1 other identifier: 2023-GEJ-IIT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction

Conditions

Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete regression (pCR) rate

  pathological complete remission (pCR) rate of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction

  3 months after the last subject participating in

Study Arms (1)

Neoadjuvant Chemoradiation

EXPERIMENTAL

neoadjuvant chemoradiation plus PD-1 antibody (Serplulimab) Intervention: Drug: Neoadjuvant chemoradiation plus PD-1 antibody(Serpluimab)

Drug: Serplulimab

Interventions

Serplulimab DRUG

PD-1 antibody

Neoadjuvant Chemoradiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically documented adenocarcinoma of Gastroesophageal Junction.
• clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
• Male or female. Age ≥ 18 years and ≤75 years.
• surgeons participating in this study consider the lesion a resectable one.
• ECOG 0\~1
• Physical condition and adequate organ function to ensure the success of abdominal surgery.
• Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
• Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
• Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
• No serious concomitant disease that will threaten the survival of patients to less than 5 years.
• Written (signed) informed consent.
• Good compliance with the study procedures, including lab and auxiliary examination and treatment.
• Female patients should not be pregnant or breast feeding.
• PD-L1 assessment

You may not qualify if:

• patients with distant metastasis or unresectable primary lesion.
• patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
• history of chemo, radiation, immune therapy or radical resection for the GEJ.
• patients with active autoimmune disease or history of refractory autoimmune disease.
• patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
• uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
• patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
• perforation / fistula of GI tract in 6 months before recruitment.
• patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-1.
• losing over 20% body weight in 2 months before recruitment.
• pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
• uncontrollable systemic diseases, including diabetes, hypertension, etc.
• severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
• patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
• patients with any cardiovascular risk factors below:

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Central Study Contacts

Zhao Lin

CONTACT

010-69156874; wz20010727@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 26, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-01

Locations

CN (1)