Immunotherapy added to standard treatment aims to stop esophageal cancer from returning
NCT ID NCT05043688
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether adding the immunotherapy drug camrelizumab to chemotherapy or chemoradiotherapy before surgery helps people with locally advanced esophageal squamous cell carcinoma. The trial enrolls adults with resectable tumors who have not received prior treatment. Participants receive one of three preoperative regimens, then undergo surgery and postoperative therapy. The goal is to see if the immunotherapy combination improves event-free survival compared with standard chemoradiotherapy alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab, an immunotherapy drug, given with chemotherapy or chemoradiotherapy before surgery
- What this could lead to
- If it works, adding camrelizumab before surgery could help people with locally advanced esophageal cancer live longer without the cancer returning.
- What could go wrong
- The trial may show no added benefit over standard chemoradiotherapy, and combining immunotherapy with chemotherapy or radiation can cause serious immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 426 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The result of pathological biopsy showed esophageal squamous cell carcinoma; 2. Have not received systemic or local treatment for esophageal cancer in the past; 3. Age 18-75 years (including 18 and 75 years old), both male and female; 4. ECOG score 0-1; 5. 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; 6. Those who are expected to achieve R0 resection; 7. Voluntarily sign an informed consent form before treatment; 8. Plan to receive surgical treatment after neoadjuvant treatment is completed; 9. No surgical contraindications; 10. Normal function of major organs 11. 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; 12. The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan; Exclusion Criteria: 1. There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery; 2. Patients with supraclavicular lymph node metastasis; 3. 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; 4. Those who are known to have a history of allergies to the drug components of this program; 5. Have received or are receiving any of the following treatments in the past: 1. Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors; 2. 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; 3. Received a live attenuated vaccine within 4 weeks before using the study drug for the first time; 4. Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time; 6. 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; 7. There are clinical symptoms or diseases of the heart that are not well controlled; 8. 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; 9. Participated in other drug clinical studies within 4 weeks before randomization; 10. 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; 11. 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; 12. 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); 13. 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; 14. Women who are pregnant or breastfeeding; 15. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anhui Provincial Hospital
Hefei, China
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Anyang Tumour Hospital
Anyang, China
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000, China
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Sun yat-sen University Cancer Center
Guangzhou, China
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Zhongshan Hospital of Fudan University
Shanghai, China
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