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Gastric CancerPhase 2NCT06202716

Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore

A Phase 2 study testing Cadonilimab plus CapeOX chemotherapy in people with Gastric Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Gastric Cancer
What is being tested?
Cadonilimab plus CapeOX chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Apr 2024to Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participate in the study, sign the informed consent form, and have good compliance;
  • Age≥ 18 years old, gender is not limited;
  • Histologically confirmed locally advanced unresectable or advanced metastatic adenocarcinoma of the stomach and gastroesophageal junction;
  • 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).
  • Her2 negative or ambiguous;
  • No prior systemic first-line therapy;
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  • 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;
  • ECOG physical condition 0 or 1 point;
  • Expected survival ≥ 3 months;
  • 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);
  • Men and women of childbearing age must use effective contraception

Who cannot join

  • Squamous cell carcinoma, undifferentiated or other non-adenocarcinoma histologic type of gastric cancer or gastro-esophageal tumor;
  • Subjects with known contraindications to cadonilimab, CapeOX (see package inserts for cadonilimab, oxaliplatin, and capecitabine);
  • 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);
  • Known history of hypersensitivity or hypersensitivity to cadonilimab, oxaliplatin, other platinum compounds, or fluorouracil;
  • Known brain or meningeal metastases:
  • 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;
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  • 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;
  • 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);
  • 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);
  • Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography of left ventricular ejection fraction <50%;
  • Known history of primary or secondary immunodeficiency virus infection
  • Concomitant active or uncontrolled severe infection
  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

Other trials in China

About this study

Official title: Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High Tumor Microenvironment Score (TMEscore).

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.

Conditions
Gastric Cancer
Being tested
Cadonilimab plus CapeOX chemotherapy
Keywords
Cadonilimab, CapeOX, First-line treatment, GC/GEJC, TMEscore
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cadonilimab plus CapeOX chemotherapyDrug

    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.

Study groups in NCT06202716
Study groupRoleWhat they receive
Cadonilimab plus CapeOX chemotherapyExperimentalEfficacy of cadonilimab plus CapeOX as first-line treatment in advanced GC/GEJC with high TMEscore.
Receives: Drug: Cadonilimab plus CapeOX chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Defined as the time between the onset of PD or death when a patient first receives the study drug, whichever occurs first.

    Measured: 3 years

Secondary outcomes (3)

  1. Overall survival (OS)

    Defined as the time between the patient's first receipt of the study drug to death.

    Measured: 3 years

  2. Objective Response Rate (ORR)

    Defined as the proportion of patients who achieved complete response (CR) or partial response (PR).

    Measured: 3 years

  3. Safety

    The occurrence of various AEs, including SAEs, will be monitored based on changes in various indicators such as vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, etc. AEs will be graded for severity according to NCI CTCAE 5.0.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202716
Sponsor's protocol ID
NFEC-2023-531
Status last verified
Mar 2024
First submitted
1 Jan 2024
Last updated
25 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab plus CapeOX chemotherapy in people with Gastric Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06202716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.

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