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Resectable Esophageal Squamous Cell CarcinomaPhase 2NCT05833971

Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing cadonilimab+chemotherapy in people with Resectable Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Guangzhou Institute of Respiratory Disease.

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 The sponsor has not verified this record for over two years, so it may be out of date.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, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
cadonilimab+chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
1 May 2023to 1 Jun 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years, both men and women
  • Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
  • Non-cervical esophageal carcinoma
  • Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
  • ECOG score 0-1
  • Life expectancy ≥12 months
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  • Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
  • For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
  • Sign the informed consent form before any trial-related procedures are implemented

Who cannot join

  • -Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
  • ulcerative esophageal squamous cell carcinoma
  • Esophageal or tracheal fistula
  • History of allergy to study drug components
  • History of immune disease
  • Patients with any serious or uncontrolled systemic disease
  • The presence of any adverse event (CTCAE>grade 1) caused by prior therapy

About this study

Official title: A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.

Being tested
cadonilimab+chemotherapy

What participants receive

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

  • cadonilimab+chemotherapyDrug

    Also called AK104

    cadonilimab plus cisplatin and Nab-PTX, Q3W

Study groups in NCT05833971
Study groupRoleWhat they receive
Experimental: cadonilimab (AK104) + chemotherapyExperimentalDrug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX
Receives: Drug: cadonilimab+chemotherapy

What is being measured

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

  1. pathologic complete response (pCR)

    Analysis of prognosis efficacy of patients: pathologic complete response (pCR)

    Measured: 1 month after resection

Secondary outcomes (5)

  1. Radical resection (R0)

    Measured: 1 month after resection

  2. Overall survival(OS)

    Measured: up to 2 years

  3. Objective response rate(ORR)

    Measured: After the start of drugs and before resection

  4. Disease control rate(DCR)

    Measured: After the start of drugs and before resection

  5. Disease-free survival(DFS)

    Measured: After resection and up to 2 years

Timeline

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

  1. First posted27 Apr 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05833971
Sponsor's protocol ID
Cadonilimab-Neoadjuvant
Status last verified
Apr 2023
First submitted
25 Feb 2023
Last updated
27 Apr 2023
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+chemotherapy in people with Resectable Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Guangzhou Institute of Respiratory Disease.

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 9 inclusion and 7 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

pathologic complete response (pCR) (time frame: 1 month after resection). 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 NCT05833971.

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 27 Apr 2023.

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