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New treatment option for Gastric Cancer
Official title A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer
ClinicalTrials.gov ID: NCT07631000
What this study is testing
What is Cadonilimab?
Cadonilimab is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of providing signed informed consent.
- Age ≥18 years at time of informed consent.
- ECOG performance status (PS) of 0 or 1 at enrollment.
- Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for...
- HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).
You likely can't join if
- Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
- HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
- Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior...
- Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.
- Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:
- Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
See the full eligibility criteria
- Capable of providing signed informed consent.
- Age ≥18 years at time of informed consent.
- ECOG performance status (PS) of 0 or 1 at enrollment.
- Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to...
- HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled.
- ALT and AST ≤2.5 x ULN
- Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)
- Measured creatinine clearance \>50 mL/min as determined by Cockcroft-Gault using actual body weight 7. Willing and able to undergo pre-treatment (during screening) and on-treatment tumor biopsies. 8\. Women of...
- Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
- HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
- Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.
- Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.
- Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:
- Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
- Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, myocardial...
- A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
- History of prior solid-organ transplant, including allogeneic bone marrow transplant.
- Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (\>10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not...
- Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or...
- Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
- Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
- Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome not excluded.
- Known hypersensitivity to any excipient contained in the formulations of study interventions.
- Prior active malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer(s), superficial bladder cancer, or carcinoma...
- Known HIV infection with detectable viral load. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Known acute hepatitis B or chronic hepatitis B infection with active untreated disease. For patients with evidence of chronic infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Known hepatitis C infection with detectable viral RNA. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
- Receipt of a live attenuated vaccine within 30 days of study treatment initiation.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.