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Esophagus CancerPhase 2EC-CRT-006NCT06143748

Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006)

A Phase 2 study testing Cadonilimab, Paclitaxel and cisplatin and intensity-modulated radiotherapy in people with Esophagus Cancer, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer. However, as high as more than 40% of patients with esophageal cancer experienced locoregional recurrence after definitive CRT. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophagus Cancer
What is being tested?
Cadonilimab, Paclitaxel and cisplatin and intensity-modulated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
2 Mar 2024to 31 Dec 2027
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

  • Histologically confirmed squamous cell carcinoma of the esophagus;
  • Locally advanced, and absence of distant metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan, stage II-IVA (according to UICC TNM version 8);
  • Not suitable for surgery (either for medical reasons or patient's choice);
  • Age at diagnosis 18 to 75 years;
  • No prior cancer therapy;
  • Estimated life expectancy >6 months;
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  • Eastern Cooperative Oncology Group performance status ≤ 2
  • No history of concomitant or previous malignancy;
  • The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥4.0×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥100×109/L; c. hemoglobin ≥9g/dL; d. serum albumin ≥2.8g/dL; e. total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate >60 mL/min;
  • Ability to understand the study and sign informed consent.

Who cannot join

  • Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
  • Patients with distant metastasis disease or esophageal fistula at diagnosis;
  • Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
  • Patients who have a preexisting or coexisting bleeding disorder;
  • Female patients who are pregnant or lactating;
  • Inability to provide informed consent due to psychological, familial, social and other factors;
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  • Presence of CTC grade ≥2 peripheral neuropathy;
  • A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
  • A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
  • Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
  • Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
  • A history of interstitial lung disease or non-infectious pneumonia;
  • A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
  • Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Cadonilimab Combined With Induction Chemotherapy and Definitive Radiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: a Phase II, Single-arm Trial (EC-CRT-006)

Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer. However, as high as more than 40% of patients with esophageal cancer experienced locoregional recurrence after definitive CRT. Immune checkpoint inhibitors targeting PD-1/PD-L1 and/or CTLA-4 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in esophageal cancer. The aim of this study was to evaluate the efficacy and safety of cadonilimab (a bispecific PD-1/CTLA-4 antibody) combined with induction chemotherapy followed by definitive radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Read the detailed description

A total of 46 patients with unresectable, locally advanced ESCC will be enrolled to receive cadonilimab plus induction chemotherapy followed by definitive radiotherapy and then 12 additional cycles of maintenance therapy with cadonilimab.

Patients will receive 2 cycles of 3-weekly schedule of induction chemotherapy, consisting of paclitaxel 135 mg/m2, cisplatin 75 mg/m2, and cadonilimab 10 mg/kg on day 1 prior to CRT. Then all patients will receive standard fractionation radiation therapy scheme: 50.4 Gy in 28 fractions, concurrently with 2 cycles of cadonilimab. After the completion of radiotherapy, patients will then receive 12 additional cycles of cadonilimab.

Being tested
Cadonilimab, Paclitaxel and cisplatin, intensity-modulated radiotherapy
Keywords
Esophageal squamous cell carcinoma, Radiotherapy, Cadonilimab, Induction chemotherapy
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • CadonilimabDrug

    Also called AK104

    Patients received cadonilimab 10 mg/kg every 3 weeks for up to 16 cycles.

  • Paclitaxel and cisplatinDrug

    Also called taxol, DDP

    Patients received 2 cycles of induction chemotherapy with paclitaxel/cisplatin (paclitaxel 135 mg/m2 and cisplatin 75 mg/m2) prior to radiotherapy. Then patients will not receive chemotherapy during radiotherapy.

  • intensity-modulated radiotherapyRadiation

    Also called IMRT

    All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.

Study groups in NCT06143748
Study groupRoleWhat they receive
The study groupExperimentalPatients will receive 2 cycles of 3-weekly schedule of induction chemotherapy, consisting of paclitaxel 135 mg/m2, cisplatin 75 mg/m2, and cadonilimab 10 mg/kg on day 1 prior to CRT. Then all patients will receive standard fractionation radiation therapy scheme: 50.4 Gy in 28 fractions, concurrently with 2 cycles of cadonilimab. After the completion of radiotherapy, patients will then receive 12 additional cycles of cadonilimab.
Receives: Drug: Cadonilimab; Drug: Paclitaxel and cisplatin; Radiation: intensity-modulated radiotherapy

What is being measured

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

  1. Progression-free survival

    Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up

    Measured: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.

Secondary outcomes (4)

  1. Overall survival

    Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up

    Measured: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months.

  2. Clinical complete response

    Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, and endoscopy with biopsies.

    Measured: 3 months after radiotherapy (plus or minus 7 days)

  3. Duration of response

    From the date of first CR/PR to the date of first PD.

    Measured: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 36 months.

  4. Treatment-related adverse events

    Incidence of treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: From date of enrollment to the date of last follow-up, 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 posted22 Nov 2023
  2. Study start2 Mar 2024
  3. Primary completion10 Jun 2026 (estimated)
  4. Study completion31 Dec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143748
Sponsor's protocol ID
B2023-425
Acronym
EC-CRT-006
Status last verified
Apr 2026
First submitted
15 Nov 2023
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gao X, Xu N, Li Z, Shen L, Ji K, Zheng Z, Liu D, Lou H, Bai L, Liu T, Li Y, Li Y, Fan Q, Feng M, Zhong H, Huang Y, Lou G, Wang J, Lin X, Chen Y, An R, Li C, Zhou Q, Huang X, Guo Z, Wang S, Li G, Fei J, Zhu L, Zhu H, Li X, Li F, Liao S, Min Q, Tang L, Shan F, Gong J, Gao Y, Zhou J, Lu Z, Li X, Li J, Ren H, Liu X, Yang H, Li W, Song W, Wang ZM, Li B, Xia M, Wu X, Ji J. Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. Lancet Oncol. 2023 Oct;24(10):1134-1146. doi: 10.1016/S1470-2045(23)00411-4.

    PubMed 37797632

  • Frentzas S, Gan HK, Cosman R, Coward J, Tran B, Millward M, Zhou Y, Wang W, Xia D, Wang ZM, Li B, Xia M, Desai J. A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors. Cell Rep Med. 2023 Nov 21;4(11):101242. doi: 10.1016/j.xcrm.2023.101242. Epub 2023 Oct 17.

    PubMed 37852261

  • Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380.

    PubMed 35108470

  • Zhu Y, Wen J, Li Q, Chen B, Zhao L, Liu S, Yang Y, Wang S, Lv Y, Li J, Zhang L, Hu Y, Liu M, Xi M. Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. Lancet Oncol. 2023 Apr;24(4):371-382. doi: 10.1016/S1470-2045(23)00060-8.

    PubMed 36990609

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab, Paclitaxel and cisplatin and intensity-modulated radiotherapy in people with Esophagus Cancer, run by Sun Yat-sen 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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?

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?

Progression-free survival (time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.). 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 NCT06143748, which also lists 4 linked publications.

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 23 Apr 2026.

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