AzTrials
AzTrials

Gastric CancerPhase 2NCT06310473

Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

A Phase 2 study testing Cadonilimab, Oxaliplatin and Capecitabine in people with Gastric Cancer and Esophagogastric Junction Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cadonilimab, Oxaliplatin and Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Mar 2024to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
  • Imaging (CT/MRI) and diagnostic laparoscopy confirmed at the stage of cT3-4aN1-3M0(AJCC 8th) .
  • Physical condition and organ function allow for for larger abdominal surgery.
  • Adequate haematological, renal and liver function.

Who cannot join

  • Patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
  • Confirmed at stage IV (AJCC 8th) or unresectable by investigator.
  • Prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer.
  • Patients are allergic to study medication and its ingredients.
  • Known active autoimmune diseases.
  • Presence of other uncontrolled serious medical conditions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guoxin Li, M.D., Ph.D contact

+86 13802771450

gzliguoxin@163.com

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510-515

    Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com

    Guoxin Li, M.D., Ph.D.

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Cadonilimab and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer : a Prospective, Open-label, Single-Arm Phase II Study

For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer.

Read the detailed description

Locally advanced esophagogastric junction and gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can downstage T and N stage, treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory.Cadonilimab (AK104), a novel bispecific antibody simultaneously targeting PD-1 and CTLA-4, was designed to boost anti-tumor activity with a favorable safety profile.This study was a single arm, open-label clinical study to evaluate the efficacy and safety of combination with Cadonilimab and Chemotherapy for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.

Being tested
Cadonilimab, Oxaliplatin, Capecitabine
Keywords
bispecific antibody, Neoadjuvant, Immunotherapy and Chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CadonilimabDrug

    Also called AK104

    10mg/kg intravenous (IV) every 3 weeks ;

  • OxaliplatinDrug

    130mg/m², iv drip for 2h, d1, q3w;

  • CapecitabineDrug

    1000mg/m² po, Bid, d1-14, q3w ;

Study groups in NCT06310473
Study groupRoleWhat they receive
Cadonilimab Plus ChemotherapyExperimentalNeoadjuvant Immunotherapy and Chemotherapy：Cadonilimab+Oxaliplatin+Capecitabine, every 3 weeks for 3 cycles; Adjuvant chemotherapy： Oxaliplatin+Capecitabine, every 3 weeks for 3-5 cycles;
Receives: Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Capecitabine

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 (6)

  1. Major pathologic response，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

  2. R0 resection rate

    Rate of microscopically margin-negative resection

    Measured: up to 1 years

  3. Objective Response Rate (ORR)

    defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.

    Measured: up to 3 years

  4. Disease Control Rate (DCR)

    defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.

    Measured: up to 3 years

  5. 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

  6. Overall Survival (OS)

    defined as the time between the date of first dose of study drug and the date of death due to any cause.

    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 posted15 Mar 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2028 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310473
Sponsor's protocol ID
NFEC-2023-582
Status last verified
Mar 2024
First submitted
20 Feb 2024
Last updated
15 Mar 2024
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 Cadonilimab, Oxaliplatin and Capecitabine in people with Gastric Cancer and Esophagogastric Junction 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Guoxin Li, M.D., Ph.D (+86 13802771450, gzliguoxin@163.com), 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 NCT06310473.

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 15 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in