To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

NCT05948449 | Unknown Phase 2

• 1 other identifier: WCH-2023-526
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

Conditions

Gastric Cancer

Keywords

gastric cancer; neoadjuvant therapy; Cadonilimab

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.

  From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Secondary Outcomes (5)

• R0 resection rate

  From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

• 2-year overall survival rate

  2 years

• 2-year disease free survival rate

  2 year

• major pathological response (MPR)

  From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

• Safety and Tolerability

  3 months after the last administration of drugs

Study Arms (1)

SOX+Cadonilimab（AK104）

EXPERIMENTAL

3 cycles of neoadjuvant therapy: S-1: 40\~60mg Bid，d1\~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w

Drug: S-1, Oxaliplatin, Cadonilimab

Interventions

S-1, Oxaliplatin, Cadonilimab DRUG

3 cycles of neoadjuvant therapy will be administered: S-1: 40\~60mg Bid，d1\~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w

SOX+Cadonilimab（AK104）

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years.
• Histologically or cytologically confirmed diagnosis of adenocarcinoma locate at gastroesophageal junction or stomach, advanced gastric or gastroesophageal junction cancer as assessed by ultrasonography and/or CT/MRI (cT3-T4a, N+, M0).
• Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
• No previous anti-tumor treatment.
• The expected survival is no less than 3 months.
• ECOG PS≤1.
• Adequate organ function including the following:
• Total bilirubin ≤1.5 times upper limit of normal (ULN),
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN,
• Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤3×ULN),
• Serum creatinine≤1.5×ULN,
• Serum amylase and lipase≤1.5×ULN,
• International standardized ratio (INR)/partial prothrombin time (PTT)≤1.5×ULN;
• Platelet count ≥ 75,000 /mm3.
• Hemoglobin (Hb) ≥ 9 g/dL.

You may not qualify if:

• Unable to comply with the research program or procedures.
• Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
• Active autoimmune disease or history of refractory autoimmune disease.
• Receiving corticosteroid (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
• Active or clinically significant cardiac disease:
• Congestive heart failure \> New York Heart Association (NYHA ) class 2;
• Active coronary artery disease;
• Arrhythmias requiring treatment other than β-blocker or digoxin;
• Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
• Evidence or history of bleeding diathesis or coagulopathy.
• Grade 3 bleeding events 4 weeks before enrollment.
• Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
• Currently taking anticoagulants.
• Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor has been cured and no evidence of disease has been found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• Patients with pheochromocytoma.

Sponsors & Collaborators

• Sichuan University: lead

Related Publications (1)

• Zhang PF, Zhang WH, Liu XJ, He D, Yang K, Gou HF, Hu JK. Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastro-oesophageal junction adenocarcinoma: study protocol for a single-arm, phase II clinical trial. BMJ Open. 2024 Dec 4;14(12):e081529. doi: 10.1136/bmjopen-2023-081529.

  PMID: 39632107 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Jiankun Hu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiankun Hu, M.D

CONTACT

+86-18980601504; hujiankun@wchscu.cn

Pengfei Zhang

CONTACT

+86-17828163584; fly_121988@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 17, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share