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

July 10, 2023 updated by: Zhen-Yu Ding, Sichuan University

The Efficacy and Safety of Chemotherapy Combined With Cadonilimab (AK104) in Neoadjuvant Treatment of Locally Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-arm, Phase II Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recent years, neoadjuvant therapy have emerged as a promising treatment option for the treatment of locally advanced gastric or gastroesophageal adenocarcinoma. However, the efficacy of current neoadjuvant regimens is still unsatisfactory. Novel treatment with higher efficacy and safety are urgently needed. Recently, immunotherapy has achieved significant therapeutic effects in the treatment of a series of cancers, and chemotherapy combined with immunotherapy has been recommended as the standard first-line treatment for gastric cancer. Moreover, several phase I/II studies have explored the efficacy and safety of chemotherapy combined with PD-1 inhibitor in the neoadjuvant treatment for gastric cancer, the results of which indicate that chemotherapy combined with immunotherapy can significantly improve the pCR rate and R0 resection rate of gastric cancer. In this study, we will evaluate the efficacy and safety of chemotherapy combined with Cadonilimab（AK104） (a PD-1/CTLA-4 bispecific antibody) in the neoadjuvant therapy for resectable locally advanced gastric or gastroesophageal adenocarcinoma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years.
  2. 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).
  3. Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
  4. No previous anti-tumor treatment.
  5. The expected survival is no less than 3 months.
  6. ECOG PS≤1.

  7. 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.
    • Absolute neutrophil count (ANC) ≥ 1500/mm3.
  8. Strict contraception.
  9. Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion Criteria:

  1. Unable to comply with the research program or procedures.
  2. Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
  3. Active autoimmune disease or history of refractory autoimmune disease.
  4. 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.

  5. 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
  6. Evidence or history of bleeding diathesis or coagulopathy.
  7. Grade 3 bleeding events 4 weeks before enrollment.
  8. Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
  9. Currently taking anticoagulants.
  10. 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.
  11. Patients with pheochromocytoma.
  12. Patients with a history of HIV infection or active hepatitis B/C.
  13. Ongoing > level 2 infection.
  14. Symptomatic brain metastasis or meningioma.
  15. Unhealed wounds, ulcers or fractures.
  16. Renal failure patients requiring blood or peritoneal dialysis.
  17. Dehydration≥ 1 grade.
  18. Epileptic that need medication.
  19. Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade).
  20. History of organ transplantation. (including corneal transplantation).
  21. Allergic to research drugs or similar drugs, or suspected allergies.
  22. Malabsorption patients.
  23. Pregnant or lactating women.
  24. Investigator believes that patients who are not suitable for the study.
  25. Medical, psychological or social conditions can affect the recruitment of patients and evaluation for study results.
  26. Other anti-tumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
  27. Previously used oxaliplatin, S-1 or Cadonilimab.
  28. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery. (excluding biliary stents, or percutaneous biliary drainage).
  29. Treatment with anti-tumor Chinese herbal medicine.
  30. History of allogeneic blood transfusion within 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOX+Cadonilimab（AK104）
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological complete response rate (pCR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2-year overall survival rate
Time Frame: 2 years
2 years
R0 resection rate
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Rate of microscopically margin-negative resection
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2-year disease free survival rate
Time Frame: 2 year
2 year
major pathological response (MPR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
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
Time Frame: 3 months after the last administration of drugs
Treatment-related adverse events as assessed by CTCAE v4.0
3 months after the last administration of drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiankun Hu, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCH-2023-526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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