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New treatment option for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Official title Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07530094
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, being studied as a potential treatment for locally advanced unresectable esophageal squamous cell carcinoma.
Also referred to as nab-paclitaxel + carboplatin, short-course definitive radiotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study...
- Age ≥ 18 years and \< 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced...
- Estimated life expectancy of at least 6 months;
- ECOG performance status score of 0-2;
You likely can't join if
- Here is the translation of the exclusion criteria into English:
- History of other malignancies;
- History of fistula caused by primary tumor infiltration;
- Patients at high risk of esophageal fistula or with signs of esophageal perforation;
- History of esophageal cancer surgery;
- Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
See the full eligibility criteria
- The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study requirements;
- Age ≥ 18 years and \< 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced unresectable ESCC (medically unsuitable for surgery or refusal of surgical...
- Estimated life expectancy of at least 6 months;
- ECOG performance status score of 0-2;
- Presence of measurable and/or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- No prior systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy, local therapy, or other investigational treatments);
- Adequate organ function, as indicated by laboratory test results obtained within 14 days prior to enrollment:
- a. Achieved without the need for blood transfusion, growth factor therapy, or other supportive medications that significantly affect neutrophil count, platelet count, or hemoglobin within ≤ 14 days before sample...
- b. Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9);
- c. Serum total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome, total bilirubin must be ≤ 3 × ULN);
- d. Aspartate aminotransferase and ALT \< 3 × ULN;
- For patients with inactive/asymptomatic carriers, chronic or active HBV infection, the following criteria must be met:
- HBV DNA \< 500 IU/mL (or 2500 copies/mL) during screening;
- Note: Patients with positive hepatitis B surface antigen or detectable HBV DNA should be managed according to treatment guidelines. Patients receiving antiviral therapy during screening must have undergone treatment for...
- Female patients of childbearing potential must voluntarily agree to use highly effective contraception during the study period, for ≥ 120 days after the last dose of camrelizumab or placebo, and for ≥ 180 days after the...
- Male patients who are not sterilized must voluntarily agree to use highly effective contraception during the study period, for ≥ 120 days after the last dose of camrelizumab or placebo, and for ≥ 180 days after the last...
- Here is the translation of the exclusion criteria into English:
- History of other malignancies;
- History of fistula caused by primary tumor infiltration;
- Patients at high risk of esophageal fistula or with signs of esophageal perforation;
- History of esophageal cancer surgery;
- Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to randomization);
- Known intolerance or resistance to the chemotherapy regimen specified in the study protocol;
- Prior receipt of any other anti-tumor therapy for ESCC (e.g., therapies targeting PD-1, PD-L1, PD-L2, or other tumor immunotherapies, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor...
- Patients with active autoimmune disease or a history of autoimmune disease that may relapse;
- Note: Patients with the following conditions are not excluded and may proceed to further screening: a. Controlled type I diabetes; b. Hypothyroidism (controlled with hormone replacement therapy only); c. Controlled...
- Cardiac chest pain occurring within ≤ 28 days prior to randomization, defined as moderate pain limiting instrumental activities of daily living;
- Symptomatic pulmonary embolism occurring within ≤ 28 days prior to randomization;
- Acute myocardial infarction occurring within ≤ 6 months prior to randomization;
- History of heart failure reaching New York Heart Association (NYHA) Class III or IV within ≤ 6 months prior to randomization;
- Ventricular arrhythmia ≥ Grade 2 occurring within ≤ 6 months prior to randomization;
- Cerebrovascular accident occurring within ≤ 6 months prior to randomization;
- Uncontrolled hypertension despite antihypertensive medication, i.e., systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, within ≤ 28 days prior to randomization;
- Syncope or seizure occurring within ≤ 28 days prior to randomization; t. History of severe hypersensitivity reaction to other monoclonal antibodies or to cisplatin or paclitaxel; u. Receipt of any chemotherapy...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.