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Locally Advanced Esophageal Squamous Cell CarcinomaNCT06715501

Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

A study testing Cadonilimab, radiotherapy and carboplatin, paclitaxel in people with Locally Advanced Esophageal Squamous Cell Carcinoma and II-IIIB Stages, run by First Affiliated Hospital of Ningbo University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single center, prospective, single arm exploratory clinical trial aimed at evaluating the efficacy and safety of sequential chemoradiotherapy combined with cetuximab in unresectable locally advanced esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cadonilimab, radiotherapy and carboplatin, paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Dec 2024to 1 Sep 2027
Phase
Interventional
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

  • Clinical diagnosis of locally advanced esophageal squamous cell carcinoma (TN+M0 or T2-3NxM0) by histological examination and/or cytological examination；
  • TNM clinical stage II-IIIB that cannot be surgically resected ;
  • ECOG score 0-1 points;
  • Expected survival ≥ 6 months;
  • Without anti-tumor treatment in the past (including but not limited to surgery, radiotherapy, chemotherapy, anti vascular therapy, immunotherapy, etc.);
  • Pathological specimens available;
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  • At least one measurable target lesion or pathological enlargement of lymph nodes with a single lymph node CT scan short diameter ≥ 15mm (according to the efficacy evaluation criteria for solid tumors RECIST 1.1) ;
  • The main organ functions well and meets the following standards:
  • Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L;
  • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min;
  • Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
  • Subjects with fertility must use appropriate contraception methods during the study period and within 120 days after the last dose. They must have a negative serum pregnancy test within 7 days before enrollment and must be non lactating subjects.

Who cannot join

  • Other malignant tumors within 5 years prior to the start of this study;
  • High risk of gastrointestinal bleeding, esophageal fistula or perforation;
  • Unrelieved toxic reactions of grade ≥ 1(excluding alopecia and fatigue; hematological toxicity must be recovered to grade ≤1 or baseline before enrollment);
  • Weight loss of ≥20% within 90 days prior to signing the informed consent form;
  • Poor nutritional status or a PG-SGA score of ≥9;
  • Any severe and/or uncontrolled diseases. This includes:
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  • Uncontrolled blood pressure (systolic pressure ≥150mmHg or diastolic pressure ≥100mmHg);
  • Suffering from grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥470ms), and grade ≥2 congestive heart failure (New York Heart Association [NYHA] classification);
  • History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases;
  • Active or uncontrolled severe infections (grade ≥2 CTCAE infections);
  • Liver cirrhosis, active hepatitis; active hepatitis (for hepatitis B: positive HBsAg and HBV DNA levels exceeding the upper limit of normal; for hepatitis C: positive HCV antibodies and HCV viral load exceeding the upper limit of normal);
  • Active syphilis;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • A history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Poorly controlled diabetes (fasting blood glucose [FBG] > 10mmol/L);
  • Major surgical treatment, incisional biopsy, or significant traumatic injury within 60 days before the start of the study; or long-term unhealed wounds or fractures;
  • Serious arterial/venous thrombotic events within 6 months before the start of the study, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • A history of substance abuse and inability to quit or with mental disorders;
  • Tumor-related symptoms and treatments:
  • Thoracic radiotherapy;
  • Traditional Chinese medicine drugs approved by the NMPA with clear anti-tumor indications in the drug instructions within 2 weeks before the start of the study (including Compound Esophageal Cancer Capsules, Kangai Injection, Kanglaite Capsules/Injection, Aidi Injection, Bitternut Oil Injection/Capsules, Xiaoai Ping Tablets/Injection, Huachansu Capsules, etc.);
  • Uncontrollable, repeatedly drained pleural effusion, pericardial effusion, or ascites (investigator's judgment);
  • Central nervous system metastasis and/or meningeal carcinomatosis;
  • Study treatment-related:
  • History of attenuated live vaccine administration within 14 days before the start of the study or plans for attenuated live vaccine administration during the study;
  • Severe hypersensitivity reactions after the use of monoclonal antibodies;
  • Active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the start of the study, excluding replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency);
  • Immunodeficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy (dose >10mg/day prednisone or other equivalent hormones) and still in use within 2 weeks of the first administration;
  • A history of active tuberculosis;
  • Participation in other clinical studies within 4 weeks before the start of the study;
  • A history of severe allergies;
  • Allergic to the active ingredients or excipients of the study drugs, such as camrelizumab, paclitaxel, carboplatin, etc.;

Trial locations and contacts

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

China1 site

  • First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315001

Other trials in China

About this study

Official title: Efficacy and Safety of Cadonilimab Combined with Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma-A Single-arm Exploratory Study

This study is a single center, prospective, single arm exploratory clinical trial aimed at evaluating the efficacy and safety of sequential chemoradiotherapy combined with cetuximab in unresectable locally advanced esophageal squamous cell carcinoma.

Patients with advanced unresectable esophageal squamous cell carcinoma who meet the criteria, after signing the informed consent form, will first receive induction therapy with cetuximab combined with paclitaxel and carboplatin chemotherapy for 2 cycles. Within 3 weeks after the second dose, RECIST v1.1 will be used for clinical tumor imaging evaluation, and if necessary, gastroscopy biopsy will be performed. Patients without progression will further receive synchronous radiotherapy and chemotherapy.

PTV-C accepts 50.4Gy, 28 times; Radiotherapy combined with paclitaxel and carboplatin weekly regimen. Within three months after completion, conduct safety assessments and preliminary evaluations of tumor response every three weeks. Consolidate treatment with cetuximab until 1 year or intolerance or disease progression occurs.

Being tested
Cadonilimab, radiotherapy, carboplatin, paclitaxel
Keywords
locally advanced ESCC, II-IIIB stage, Cadonilimab, Chemoradiotherapy

What participants receive

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

  • CadonilimabDrug

    Cadonilimab is a PD-1/CTLA-4 bispecific antibody. The drug is administered at a fixed dose of 10mg/kg, intravenously (i.v.), on day 1, every 3 weeks (q3w), until disease progression or intolerable toxicity occurs, with a maximum treatment duration of 1 year.

  • radiotherapyRadiation

    GTV is defined as visible lesions (GTVp: primary lesion; GTVn: metastatic lymph nodes), CTVp is defined as 3cm above and below the primary lesion, with 0.5cm outward expansion around the periphery, and CTVn is defined as 0.5cm outward expansion of GTVn; PTVp is an outward expansion of 0.5cm for CTVp, and PTVn is an outward expansion of 0.5cm for CTVn. Radiotherapy dose: DT50.4Gy/28f, once daily, 5 times a week

  • carboplatin, paclitaxelDrug

    Induction chemotherapy: carboplatin 5AUC，q3w; Paclitaxel 135mg/m2,q3w. Simultaneous chemotherapy: 2AUC/W，total 5w; Paclitaxel 50mg/m2/w，total 5w

Study groups in NCT06715501
Study groupRoleWhat they receive
Cadonilimab combined with ChemoradiotherapyExperimentalPatients with advanced unresectable esophageal squamous cell carcinoma who meet the criteria, will first receive induction therapy with cetuximab combined with paclitaxel and carboplatin chemotherapy for 2 cycles. Within 3 weeks after the second dose, RECIST v1.1 will be used for clinical tumor imaging evaluation. Patients without progression will further receive synchronous radiotherapy and chemotherapy. PTV-C accepts 50.4Gy, 28 times; Radiotherapy combined with paclitaxel and carboplatin weekly regimen. Within three months after completion, conduct safety assessments and preliminary evaluations of tumor response every three weeks. Consolidate treatment with cetuximab until 1 year or intolerance or disease progression occurs.
Receives: Drug: Cadonilimab; Radiation: radiotherapy; Drug: carboplatin, paclitaxel

What is being measured

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

  1. 2-year progression free survival rate

    Measured: 2 year after the end of treatment

  2. Incidence of Treatment-Emergent Adverse Events

    The incidence of adverse events (AE) and serious adverse events (SAE) within three months after radiotherapy, and the incidence of treatment termination caused by AE/SAE

    Measured: Within three months after radiotherapy

Secondary outcomes (2)

  1. Progression free survival (PFS)

    Measured: From the randomization date until the first recorded date of progression or death from any cause, whichever comes first, assessed up to 36 months

  2. Overall survival (OS)

    Measured: From the randomization date until death from any cause，assessed up to 36 months

Timeline

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

  1. First posted4 Dec 2024
  2. Study start1 Dec 2024
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2027 (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 N/A
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
NCT06715501
Sponsor's protocol ID
AK104-IIT-C-E-0195
Status last verified
Mar 2025
First submitted
21 Nov 2024
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Cadonilimab, radiotherapy and carboplatin, paclitaxel in people with Locally Advanced Esophageal Squamous Cell Carcinoma and II-IIIB Stages, run by First Affiliated Hospital of Ningbo 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 12 inclusion and 32 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: enrolling by invitation, as of the sponsor's last update on 25 Mar 2025. 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.

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?

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?

2-year progression free survival rate (time frame: 2 year after the end of treatment). The study lists 2 primary outcomes in all. 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 NCT06715501.

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 2025.

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