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Resectable Esophageal Squamous Cell CarcinomaPhase 3NCT05043688

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.

A Phase 3 study testing Camrelizumab and radiotherapy in people with Resectable Esophageal Squamous Cell Carcinoma, run by Zhigang Li at 5 sites 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

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab and radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
426 participants
Where
5 sitesChina
Study dates
1 Sep 2021to 31 Dec 2030
Phase
Phase 3
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

  • The result of pathological biopsy showed esophageal squamous cell carcinoma;
  • Have not received systemic or local treatment for esophageal cancer in the past;
  • Age 18-75 years (including 18 and 75 years old), both male and female;
  • ECOG score 0-1;
  • Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
  • Those who are expected to achieve R0 resection;
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  • Voluntarily sign an informed consent form before treatment;
  • Plan to receive surgical treatment after neoadjuvant treatment is completed;
  • No surgical contraindications;
  • Normal function of major organs
  • Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;
  • The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan;

Who cannot join

  • There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
  • Patients with supraclavicular lymph node metastasis;
  • Poor nutritional status, BMI <18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
  • Those who are known to have a history of allergies to the drug components of this program;
  • Have received or are receiving any of the following treatments in the past:
  • Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
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  • Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose>10mg/day prednisone or equivalent dose); if there is no active autoimmune disease In the case of inhalation or topical use of steroids and prednisone doses> 10 mg/day or equivalent doses of adrenal cortex hormone replacement are allowed;
  • Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;
  • Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
  • A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • There are clinical symptoms or diseases of the heart that are not well controlled;
  • Severe infections (CTCAE v5.0> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;
  • Participated in other drug clinical studies within 4 weeks before randomization;
  • People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;
  • Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;
  • There is active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);
  • Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate> 90%), such as fully treated skin basal cell carcinoma or squamous cell Skin cancer or cervical carcinoma in situ, etc., may be considered for inclusion;
  • Women who are pregnant or breastfeeding;
  • According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, alcoholism, drug abuse, family or social factors, which may affect the subjects Factors of safety or compliance.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Anyang Tumour Hospital

    Anyang

  • Sun yat-sen University Cancer Center

    Guangzhou

  • Anhui Provincial Hospital

    Hefei

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200000

  • Zhongshan Hospital of Fudan University

    Shanghai

Other trials in China

About this study

Official title: Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.

Read the detailed description

This study aimed to evaluate the efficacy and safety of adding immunotherapy to neoadjuvant chemotherapy (CT) or chemoradiotherapy (CRT) compared to neoadjuvant CRT alone for resectable locally advanced esophageal squamous cell carcinoma (ESCC)

Being tested
Camrelizumab, radiotherapy

What participants receive

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

  • CamrelizumabDrug

    The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

  • radiotherapyRadiation

    The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

Study groups in NCT05043688
Study groupRoleWhat they receive
Neoadjuvant Chemotherapy With CamrelizumabExperimentalChemotherapy: Paclitaxel（Albumin Bound）100mg/m2, Day 1,8,15，Carboplatin AUC=5mg/ml/min, Day 1； Camrelizumab: Day 1, every 3 weeks, 2 cycles; Postoperative adjuvant treatment: Camrelizumab maintenance
Receives: Drug: Camrelizumab
Neoadjuvant Radiochemotherapy With CamrelizumabExperimentalChemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Camrelizumab: 200mg，Day 1,22 Radiotherapy: 41.4 Gy , D1-5/W Postoperative adjuvant treatment：Camrelizumab maintenance
Receives: Drug: Camrelizumab; Radiation: radiotherapy
Neoadjuvant RadiochemotherapyActive comparatorChemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Radiotherapy：41.4 Gy , D1-5/W. Postoperative adjuvant treatment: non-pCR: Camrelizumab maintenance; PCR: surveillance
Receives: Radiation: radiotherapy

What is being measured

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

  1. EFS assessed by the investigator according to RECIST 1.1

    defined as event free survival,defined as the time from randomization to the occurrence of tumor progression/recurrence /death, whichever comes first

    Measured: median EFS approximately over 45 months

Secondary outcomes (7)

  1. OS

    defined as the time from registration to death due to any cause, or censored at date last known alive

    Measured: median OS approximately over 80 months

  2. R0 resection rate

    defined as complete surgery resection rate

    Measured: within 28 working days after surgery

  3. DFS

    defined as the time from the date of surgery who completed R0 resection to local or distant recurrence, or death due to any cause, whichever occurs first;

    Measured: median DFS approximately over 40 months

  4. HRQoL

    defined as quality and nutrition assessment

    Measured: approximately 48 months

  5. pCR

    pCR is defined as pathological complete response(ypT0/TisN0)

    Measured: within 28 working days after surgery

  6. MPR

    MPR is defined as the percentage of subjects with <10% residual tumor in the primary tumor site

    Measured: within 28 working days after surgery

  7. Adverse events (AEs)

    Incidence and grade (including serious adverse events [SAEs] and immune-related adverse events [irAEs]), determined according to the NCI-CTCAE 5.0 criteria

    Measured: through study completion, assessed up to 50 months

Timeline

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

  1. First posted14 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
426 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043688
Sponsor's protocol ID
LS2160
Status last verified
Sep 2026
First submitted
5 Sep 2021
Last updated
17 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang Y, Zhu L, Cheng Y, Liu Z, Cai X, Shao J, Zhang M, Liu J, Sun Y, Li Y, Yi J, Yu B, Jiang H, Chen H, Yang H, Tan L, Li Z. Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study). BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6.

    PubMed 35524205

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab and radiotherapy in people with Resectable Esophageal Squamous Cell Carcinoma, run by Zhigang Li at 5 sites 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 19 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

EFS assessed by the investigator according to RECIST 1.1 (time frame: median EFS approximately over 45 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 NCT05043688, 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 17 Sep 2026.

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