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New treatment option for Esophageal Cancer
Official title A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
ClinicalTrials.gov ID: NCT06792786
What this study is testing
- What it's testing
- Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC.
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
- All people must sign an informed consent form before initiating any study-related procedures;
- All patients must be aged ≥18 years and ≤75 years;
- Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
- Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
You likely can't join if
- Insufficient tissue/blood sample available before treatment as required for the study;
- Patient refusal to undergo dynamic ctDNA testing;
- The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of...
- History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in...
- History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy...
- Severe cardiovascular or cerebrovascular diseases;
See the full eligibility criteria
- All people must sign an informed consent form before initiating any study-related procedures;
- All patients must be aged ≥18 years and ≤75 years;
- Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
- Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
- ECOG performance status of 0-1;
- Laboratory test values within the following limits before the first dose of the investigational drug:
- Hematology: WBC ≥3.0×10⁹/L; ANC ≥1.5×10⁹/L; PLT ≥70×10⁹/L; HGB ≥9.0 g/dL;
- Liver function: AST ≤2.5×ULN; ALT ≤2.5×ULN;
- Renal function: Cr ≤1.5×ULN or CrCl ≥40 mL/min;
- Coagulation: INR ≤1.5, APTT ≤1.5×ULN;
- Other: Lipase ≤1.5×ULN, unless clinically/radiographically insignificant if lipase \>1.5×ULN.
- Insufficient tissue/blood sample available before treatment as required for the study;
- Patient refusal to undergo dynamic ctDNA testing;
- The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;
- History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate...
- History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
- Severe cardiovascular or cerebrovascular diseases;
- History of interstitial lung disease or active pneumonia/tuberculosis;
- Severe allergic reactions to paclitaxel/cisplatin or any monoclonal antibody;
- Any other condition deemed inappropriate for participation in this study as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Jinhua, Zhejiang, China
- Lishui, Zhejiang, 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 Jinhua, Zhejiang, China; Lishui, Zhejiang, 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.