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Unresectable Esophageal Squamous Cell CarcinomaPhase 2NCT05522894

AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

A Phase 2 study testing AK104, Cisplatin and Paclitaxel in people with Unresectable Esophageal Squamous Cell Carcinoma and Locally Advanced Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AK104, Cisplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 1 Oct 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

  • Age: 18 to 75 years old, men or women are not limited
  • Histologically or cytologically confirmed as esophageal squamous cell carcinoma (including the gastroesophageal junction), (adenosquamous carcinoma with a predominantly squamous component is allowed)
  • Unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
  • Patients who have never received systemic antitumor therapy
  • ECOG score 0-1
  • Patients who have measurable lesions that meet RECIST 1.1 criteria
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  • Patients who are expected to survive more than 3 months
  • Women of childbearing age must have a negative pregnancy test (serum or urine) and voluntarily use an appropriate method of contraception
  • Patients who are voluntarily enrolled in the study and sign an informed consent form (ICF)
  • Patients who are well adherent and able to follow up the study protocol
  • Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency diseases.
  • Patients with normal coagulation function, no active bleeding, and thrombotic disease
  • cohort A: AK104 monotherapy cohort enrolling patients with esophageal cancer tumor tissue PD-L1 CPS ≥ 5 (uniformly using Dako 22C3 antibody)

Who cannot join

  • Locally advanced esophageal cancer that can be radically resectable or potentially cured by radiotherapy
  • 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
  • Symptomatic central nervous system metastases (brain metastases confirmed stable by imaging for more than 3 months can be enrolled)
  • A serious infection (CTCAE > grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious comorbidities that occurred within 4 weeks prior to the first administration of the study drug; baseline chest imaging suggestive of active pulmonary inflammation with clinically relevant signs or symptoms; signs and symptoms of infection within 2 weeks prior to the first administration of study drug, or requiring oral, or intravenous antibiotic therapy. Excluding prophylactic use of antibiotics
  • Patients with previous and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with radiation pneumonia within 6 months
  • Patients with active tuberculosis infection detected by history or CT examination, patients with a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment
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  • Patients previously treated with immune checkpoint inhibitors
  • Patients who have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection of the assay) or combined hepatitis B and hepatitis C co-infection
  • Patients who have a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • The presence of thrombosis-type diseases or using anticoagulant drugs
  • Patients with any serious or uncontrolled systemic disease that, in the opinion of the investigator, may increase the risk associated with participation

Trial locations and contacts

No sites are listed yet.

Yun Liu, M.D. contact

010-87788102

medliuyun@163.com

About this study

Official title: A Multicenter, Phase II Clinical Study of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) Alone or in Combination With Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

This is a two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy.

Read the detailed description

During the treatment, eligible patients in cohort A with PD-L1 CPS ≥5 will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing); in cohort B, regardless of PD-L1 expression, eligible patients will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing), in combination with cisplatin (75 mg/m2) and paclitaxel (175 mg/m2), Q3W (up to 6 cycles, the specific cycles will be determined by the investigator). Thereafter, AK104 maintenance therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, death, or end of the study, whichever occurred first (maximum duration of treatment with AK104 should be less than 12 months). When patients with initially unresectable disease transformed into resectable, an operation can be considered and the original regimen may be used after surgery.

Being tested
AK104, Cisplatin, Paclitaxel
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • AK104Drug

    Also called Cadonilimab

    10mg/kg IV every 3 weeks (Q3W)

  • CisplatinDrug

    Also called DDP

    75mg/m2 IV every 3 weeks (Q3W)

  • PaclitaxelDrug

    Also called PTX

    175mg/m2 IV every 3 weeks (Q3W)

Study groups in NCT05522894
Study groupRoleWhat they receive
Cohort AExperimentalAK104 alone
Receives: Drug: AK104
Cohort BExperimentalAK104 in combination with chemotherapy
Receives: Drug: AK104; Drug: Cisplatin; Drug: Paclitaxel

What is being measured

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

  1. Objective response rate (ORR)

    ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  2. Overall survival (OS)

    Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.

    Measured: Up to approximately 2 years

  3. Disease control rate (DCR)

    Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.

    Measured: Up to approximately 2 years

  4. Duration of response (DoR)

    Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) (as per RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  5. Incidence and severity of adverse events(AEs)

    Incidence and severity of AEs is aim to evaluate the safety of AK104 alone or combination with chemotherapy.

    Measured: Up to approximately 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 posted31 Aug 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Oct 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522894
Sponsor's protocol ID
NCC3649
Status last verified
Aug 2022
First submitted
26 Aug 2022
Last updated
31 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qu W, Gao J, Zhang B, Yang M, Wang Y, Liu Y, Guo Y, Guo S, Huang J. Cadonilimab combined with taxane and cisplatin as the first-line treatment of advanced esophageal squamous cell carcinoma: an open-label, multicenter phase II trial. J Immunother Cancer. 2025 Oct 30;13(10):e012869. doi: 10.1136/jitc-2025-012869.

    PubMed 41167638

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104, Cisplatin and Paclitaxel in people with Unresectable Esophageal Squamous Cell Carcinoma and Locally Advanced Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences.

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 13 inclusion and 11 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 31 Aug 2022. 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?

Contact Yun Liu, M.D. (010-87788102, medliuyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 2 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 NCT05522894, which also lists 1 linked publication.

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 31 Aug 2022.

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