Trial Title:
Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore
NCT ID:
NCT06202716
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Cadonilimab
CapeOX
First-line treatment
GC/GEJC
TMEscore
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab plus CapeOX chemotherapy
Description:
Cadonilimab plus oxaliplatin/capecitabine (CapeOX) chemotherapy as first-line treatment
in patients with advanced gastric cancer or gastro-esophageal junction adenocarcinoma:
Cadonilimab 10mg/kg, iv, q3w + oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po,
bid, d1-d4, q3w (3 weeks as a cycle, a maximum of 8 cycles of treatment). Then the
maintenance treatment phase with tislelizumab + lenvatinib is entered, and the specific
dosage is the same as the treatment period.
Arm group label:
Cadonilimab plus CapeOX chemotherapy
Summary:
This is a single-arm, open-label, multi-center clinical study to evaluate the efficacy
and safety of PD-1/CTLA-4 bispecific cadonilimab in combination with
oxaliplatin/capecitabine (CapeOX) in the first-line treatment of advanced gastric cancer
or gastro-esophageal junction adenocarcinoma with a high tumor microenvironment score
(TMEscore). The study plans to enroll 50 patients to receive cadonilimab 100mg/kg, iv,
q3w + CapeOX (oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, D1-14, q3w,
with 3 weeks as a cycle and a maximum of 8 cycles of treatment. Then the maintenance
treatment phase with cadonilimab ± capecitabine is entered, and the specific dosage is
the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) using
RECISIT 1.1 until disease recurrence, metastasis, death, or loss of follow-up. The
primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients voluntarily participate in the study, sign the informed consent form, and
have good compliance;
2. Age≥ 18 years old, gender is not limited;
3. Histologically confirmed locally advanced unresectable or advanced metastatic
adenocarcinoma of the stomach and gastroesophageal junction;
4. The tumor tissue was tested by the tumor microenvironment in the laboratory of the
Department of Oncology, Nanfang Hospital, Southern Medical University, and was
defined as a high tumor microenvironment score (TMEscore).
5. Her2 negative or ambiguous;
6. No prior systemic first-line therapy;
7. Subjects who have received prior adjuvant chemotherapy or neoadjuvant chemotherapy
with curative intent or definitive chemo-radiotherapy for advanced disease are
eligible if progression occurs >6 months after the previous treatment;
8. ECOG physical condition 0 or 1 point;
9. Expected survival ≥ 3 months;
10. Blood tests (without transfusion within 14 days) 1) Absolute neutrophil ≥1.5×109/L,
platelet ≥100×109/L, hemoglobin ≥90g/L); 2) Liver function tests (aspartate
aminotransferase and glutamate aminotransferase ≤3× ULN, bilirubin ≤1.5×ULN; in case
of liver metastases, AST and ALT ≤5×ULN); 3) renal function (serum creatinine ≤
1.5×ULN, or creatinine clearance (CCr) ≥60ml/min);
11. Men and women of childbearing age must use effective contraception
Exclusion Criteria:
1. Squamous cell carcinoma, undifferentiated or other non-adenocarcinoma histologic
type of gastric cancer or gastro-esophageal tumor;
2. Subjects with known contraindications to cadonilimab, CapeOX (see package inserts
for cadonilimab, oxaliplatin, and capecitabine);
3. Known history of severe intolerance to cadonilimab, oxaliplatin, or capecitabine
(i.e., grade 4 toxicity of one of the agents; grade 3-4 toxicity of other
concomitant agents is not excluded);
4. Known history of hypersensitivity or hypersensitivity to cadonilimab, oxaliplatin,
other platinum compounds, or fluorouracil;
5. Known brain or meningeal metastases:
6. Radiotherapy or any anti-tumor therapy (chemotherapy, targeted therapy,
immunotherapy, radio-frequency ablation, traditional Chinese medicine with
anti-tumor indications, immunomodulators or tumor embolization, etc.) within 4 weeks
prior to the first dose of study treatment;
7. Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other
antibody or drug therapy against T cell co-stimulation or checkpoint pathways;
8. Patients have had other malignancies within the past 5 years or at the same time
(except for cured basal cell carcinoma of the skin and carcinoma in situ of the
cervix);
9. There are obvious clinical bleeding symptoms or obvious bleeding tendency,
hemoptysis, etc. within 3 months before treatment. or venous/venous thrombotic event
treatment within the preceding 6 months, such as cerebrovascular accident (including
transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein
thrombosis, and pulmonary embolism; or requiring long-term anticoagulation with
warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin≥ 300
mg/day or clopidogrel ≥75 mg/day);
10. Active heart disease, including myocardial infarction, severe/unstable angina, 6
months prior to treatment. Echocardiography of left ventricular ejection fraction
<50%;
11. Known history of primary or secondary immunodeficiency virus infection
12. Concomitant active or uncontrolled severe infection
13. Any other disease, clinically significant metabolic abnormality, physical
examination abnormality, or laboratory abnormality that, in the judgment of the
investigator, has reason to suspect that the patient has a certain disease or state
that is not suitable for the use of the study drug;
14. Any condition that, in the opinion of the investigator, may put subjects treated
with study drug at risk, interfere with the study drug, subject safety assessment,
or interpretation of results.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Start date:
April 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06202716
