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Locally Advanced Unresectable Gastric AdenocarcinomaPhase 2NCT05974059

Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer

A Phase 2 study testing Oxaliplatin, Capecitabine and Cadonilimab in people with Locally Advanced Unresectable Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Oxaliplatin, Capecitabine and Cadonilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Aug 2023to 1 Aug 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years ≤ age ≤ 75 years;
  • ECOG score 0-1;
  • Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction.
  • c stageII, III(T1-4a/N+ M0, T3-4a/N-M0, AJCC 8th edition of gastric cancer cTNM stage) were performed according to enhanced CT/MRI examination (combined with ultrasonic gastroscopy and diagnostic laparoscopy if necessary).
  • The study site and the operator can complete radical dissection of D2 lymph nodes (the number of examined lymph nodes must be at least 15 to ensure the operation quality), and R0 resection;
  • Physical condition and organ function allow for larger abdominal surgery;
Show all 26Show fewer
  • It has adequate organ and bone marrow functions and is defined as follows:
  • 1)Blood routine test: absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count(PLT)≥100×109/L; Hemoglobin (HGB)≥9.0 g/dL; 2)Liver function: Total serum bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) is required for patients without liver metastasis. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5ULN; 3)Renal function: creatinine clearance rate (Ccr)≥50 mL/min (calculated by Cockcroft/Gault formula); a Female: Ccr= (140-years) x Body Weight (kg) x 0.85 72 x serum creatinine (mg/dL) b Males: Ccr= (140-years) x Weight (kg) x 1.00 72 x serum creatinine (mg/dL) 4) Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the intended range of the anticoagulant; 8 Left ventricular ejection fraction (LVEF)≥50% confirmed by echocardiography; 9 Agree and be able to comply with the protocol during the study; 10 Provide written informed consent prior to entering study screening and the patient is aware that she can withdraw from the study at any time during the study without loss; 11 Consent to provide blood and histological specimens
  • Exclusion Criteria
  • Complication of upper gastrointestinal tract obstruction/hemorrhage or digestive dysfunction or malabsorption syndrome;
  • Concomitant severe uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury;
  • Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy;
  • Other malignancies (except basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
  • Uncontrolled pleural effusion, pericardial effusion or ascites;
  • Serious cardiovascular disease such as symptomatic coronary heart disease, congestive heart failure ≥Grade II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment;
  • Allergic reaction to the drugs used in this study;
  • Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment;
  • Patients receiving study medication within 4 weeks prior to enrollment (participating in other clinical trials);
  • Active autoimmune diseases;
  • Medical history of primary immunodeficiency;
  • Immunosuppressive medications were used within 4 weeks prior to the first dose of study treatment, excluding nasal spray, inhaled or other local corticosteroids or physiological doses of systemic corticosteroids (i.e. not more than 10 mg/day prednisone or equivalent dose of other corticosteroids), or the use of hormones to prevent contrast agent allergy;
  • Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study treatment or scheduled for the duration of the study;
  • Known active tuberculosis;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV);
  • Pregnant or lactating women;

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Xuewei Ding, MD contact

18622220158

xding@tmu.edu.cn

China1 site

  • Xuewei Ding

    Tianjin, Tianjin Municipality, 300308

    Xuewei Ding, MD, 18622220158, xding@tmu.edu.cn

Other trials in China

About this study

Official title: Single-arm, Open-label, Single-center Phase II Clinical Study of Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer

The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.

Read the detailed description

This study was a single arm, open-label, single-center clinical study to evaluate the efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.

Being tested
Oxaliplatin, Capecitabine, Cadonilimab
Keywords
Resectable locally advanced adenocarcinoma of the gastro-esophageal junction

What participants receive

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

  • OxaliplatinDrug

    Preoperative treatment：130mg/m2，iv, 2h，d1，Q3W; Postoperative treatment：130mg/m2，iv, 2h，d1，Q3W;

  • CapecitabineDrug

    Preoperative treatment：1000 mg /m2, PO，bid d1-14，Q3W； Postoperative treatment：1000 mg /m2, PO，bid. d1-14，Q3W；

  • CadonilimabDrug

    Cadonilimab 10 mg/kg, d1, Q3W

Study groups in NCT05974059
Study groupRoleWhat they receive
CadonilimabExperimental10 mg/kg, d1, Q3W;
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Cadonilimab

What is being measured

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

  1. Pathologic complete remission rate (PCR)

    Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.

    Measured: up to 1 years

Secondary outcomes (5)

  1. 3-year disease-free survival rate of 3year (DFS)

    3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment

    Measured: up to 3 years

  2. Major pathological response rate (MPR)

    Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist

    Measured: up to 1 years

  3. Objective response rate(ORR)

    Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR

    Measured: up to 3 years

  4. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD

    Measured: up to 3 years

  5. Adverse Events（AEs）

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

    Measured: up to 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 posted3 Aug 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974059
Sponsor's protocol ID
AK104-IIT-C-N1-0036
Status last verified
Jul 2023
First submitted
24 Jul 2023
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
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 Oxaliplatin, Capecitabine and Cadonilimab in people with Locally Advanced Unresectable Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 26 inclusion and 0 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 3 Aug 2023. 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?

Contact Xuewei Ding, MD (18622220158, xding@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete remission rate (PCR) (time frame: up to 1 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 NCT05974059.

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 3 Aug 2023.

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