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New treatment option for Esophageal Cancer
Official title DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI
ClinicalTrials.gov ID: NCT07162506
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for esophageal cancer.
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 is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy. A total of 120 eligible subjects will be enrolled.
- Phase 2: a mid-size study of how well it works
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
- Volunteered to participate, cooperated with follow-up visits.
- Aged 18 - 75 years (inclusive), male or female.
- Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC)...
- Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
You likely can't join if
- Surgery for esophageal cancer;
- Esophageal fistulae due to infiltration of the primary tumor；
- Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
- Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
- Major surgery or severe trauma within 4 weeks prior to first use of study drug;
- Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
See the full eligibility criteria
Who can join
- Volunteered to participate, cooperated with follow-up visits.
- Aged 18 - 75 years (inclusive), male or female.
- Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR/PR after 2-3 cycles of platinum-based chemotherapy...
- Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Estimated survival time ≥ 3 months.
- The function of major organs meets the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
- Platelets ≥ 80×10\^9/L;
- Hemoglobin ≥ 9g/dL;
- Serum albumin ≥ 2.8g/dL;
- Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN;
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (people on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within...
- Comprehensive baseline staging evaluation prior to induction chemo-immunotherapy, including esophagogastroduodenoscopy (with biopsy) and/or endoscopic ultrasonography (EUS), contrast-enhanced CT of the neck, chest, and...
- Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of...
What rules you out
- Surgery for esophageal cancer;
- Esophageal fistulae due to infiltration of the primary tumor；
- Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
- Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
- Major surgery or severe trauma within 4 weeks prior to first use of study drug;
- Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- Received or receiving any of the following treatments in the past:
- Radiotherapy or targeted therapy;
- Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
- Systemic treatment with corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment (except for the use of...
- Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
- Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism...
- Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
- Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or...
- Severe infections (CTCAE \> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging...
- History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
- Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);
- Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to enrollment that do not improve with treatment;
- Known hypersensitivity to large protein preparations, or to any of the components of camrelizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or carboplatin or to any of the components used...
- Previously diagnosed with any other malignancy within 5 years before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\>90%), such as...
- As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 Tianjin, Tianjin Municipality, 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.