Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Camrelizumab with chemoradiotherapy to preserve organs in locally advanced resectable ESCC

Official title: Exploratory Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy as an Organ-preserving Strategy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Run by The First Affiliated Hospital of Henan University of Science and Technology · NCT07622797 · Data updated 2026-11-12

This study tests whether adding camrelizumab to chemoradiotherapy can help preserve the esophagus in adults with locally advanced, resectable esophageal squamous cell carcinoma.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment164 (estimated)
SponsorThe First Affiliated Hospital of Henan University of Science and Technology
Academic / other
Drugs / interventionschemotherapy, prednisone, camrelizumab
Locations1 site (Luoyang, Henan)
StatusRecruiting
StartedNovember 21, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedJune 3, 2026
Trial IDNCT07622797 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with locally advanced, resectable ESCC stage II–IVa (cT1b-4aN0-3M0), ECOG 0–1, no prior therapy for esophageal cancer, and adequate organ function.

Probably not a fit

Patients with contraindications to immunotherapy, intolerance to chemoradiotherapy, or disease characteristics outside the specified staging criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, open-label, exploratory study evaluating camrelizumab plus concurrent chemoradiotherapy as an organ-preserving approach for locally advanced resectable ESCC. Two cohorts compare different chemoradiotherapy backbones alongside camrelizumab: one with nab-paclitaxel, carboplatin, and radiotherapy; the other with radiotherapy and capecitabine plus camrelizumab. Eligible adults with stage II–IVa ESCC (cT1b-4aN0-3M0), good performance status, and adequate organ function are enrolled after screening, with a target of 164 participants. Primary goals include feasibility and safety of this combined regimen as an organ-saving strategy, with follow-up on treatment-related adverse events and preliminary efficacy signals.

Why it matters

Potential benefit: If successful, this approach could increase the chances of preserving the esophagus while achieving disease control in eligible patients.

How similar studies have gone: Early trials using PD-1 inhibitors with chemoradiation in thoracic cancers have shown tolerability and signals of activity; this specific organ-preserving strategy is exploratory in ESCC.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1\. Age ≥18 years old; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Patients with locally advanced resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC; 4. Have not received chemotherapy, radiotherapy, or surgical treatment for esophageal cancer; 6. ECOG performance status: 0-1; 7. Expected survival ≥12 weeks; 8. Within 7 days prior to enrollment, the participant's blood routine and biochemical indicators meet the following criteria:

  1. Hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; platelets ≥100 × 10\^9/L (patients must not have received blood transfusion or growth factor support within 14 days before blood sampling);
  2. ALT and AST ≤2.5 times the upper limit of normal (ULN); ALP ≤2.5 times ULN;
  3. Total serum bilirubin \<1.5 times ULN (patients with Gilbert's syndrome may enroll if total bilirubin \<3 times ULN);
  4. Serum creatinine \<1.5 times ULN or estimated glomerular filtration rate ≥60 ml/min/1.73 m²;
  5. Serum albumin ≥30 g/L;
  6. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is on anticoagulant therapy and PT value is within the expected therapeutic range;
  7. Activated partial thromboplastin time (APTT) ≤1.5 times ULN. 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).

     10\. Women of childbearing potential must agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study; must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding; men must agree to use contraceptive measures during the study and for 6 months after the study.

     11\. No severe comorbidities that would result in a life expectancy of less than 5 years.

     12\. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

     Exclusion Criteria:
* 1\. Individuals allergic to the treatment drugs; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 3. Active or uncontrolled severe infection (≥ CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, or unexplained fever \>38.5°C before the first administration; 4. Individuals with a history of mental drug abuse who cannot quit or have psychiatric disorders; 5. Subjects who have had or currently have other malignancies requiring active treatment within the past 5 years (fully treated cases with an expected 5-year survival \>90%, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ, are excluded from this restriction); 6. Uncorrectable coagulation disorders; 7. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure NYHA class ≥2; ventricular arrhythmias requiring drug treatment (including QTc interval ≥450 ms for men, ≥470 ms for women); left ventricular ejection fraction (LVEF) \<50%; 8. Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, uncontrolled diabetes, or other types of systemic diseases; 9. Patients whose imaging shows the tumor has invaded major blood vessels, or for whom the investigator judges that the tumor is highly likely to invade major blood vessels during the study period and cause fatal bleeding; 10. Presence of active autoimmune disease or immunodeficiency, or the following history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc. The following exceptions apply: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be enrolled. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study.

  11\. Patients who are using immunosuppressive agents or systemic corticosteroid therapy for immunosuppression purposes (dose \>10 mg/day of prednisone or other equivalent steroids, and continued use within 2 weeks prior to enrollment); 14. Underwent surgery within 28 days before enrollment in this study (excluding biopsy) or whose surgical incision has not fully healed; 15. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent; 16. Pregnant women (positive pregnancy test before taking the drug) or women who are breastfeeding; 17. Patients deemed unsuitable for enrollment based on the investigator's judgment.

Where it's running

  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.