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New treatment option for Borderline Resectable Carcinoma
Official title Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07339488
What this study is testing
What is PD-1/PD-L1 inhibitors?
PD-1/PD-L1 inhibitors is an investigational medicine, being studied as a potential treatment for borderline resectable carcinoma.
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
- Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type.
- 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
- Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.
- Age ≥18 years and ≤75 years; both sexes are eligible.
- ECOG performance status score of 0-1.
- Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.
- Thoracic esophageal cancer.
You likely can't join if
- Patients with distant metastases other than supraclavicular lymph node metastases.
- Presence or high risk of esophageal perforation.
- Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.
- Patients who previously experienced unacceptable toxicity after receiving ICI therapy.
- Patients with a history of thoracoabdominal/pelvic radiotherapy within 6 months prior to enrollment.
- Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose...
See the full eligibility criteria
- Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.
- Age ≥18 years and ≤75 years; both sexes are eligible.
- ECOG performance status score of 0-1.
- Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.
- Thoracic esophageal cancer.
- Unresectable lesions, defined as: T4 stage; marginally resectable T3 stage (invading other organs, e.g., trachea, bronchus, or aorta not ruled out by imaging); presence or absence of unresectable lymph nodes or...
- No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.
- Baseline laboratory requirements (within 7 days prior to enrollment): Hematology:
- Hb≥90 g/L (no transfusion within 14 days)
- NEUT ≥1.5×10⁹/L
- PLT ≥100×10⁹/L
- WBC≥3×10⁹/L Biochemistry:
- ALT and AST≤2.5×ULN
- TBIL≤1.5×ULN
- SCr≤1.5×ULN; or CrCl≥60 mL/min Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3/FT4 levels should also be considered; eligible if FT3/FT4 are normal) Echocardiography: LVEF≥50%
- Female people need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male people must agree to use contraception...
- No psychological, familial, social, or geographical factors that may impair protocol adherence.
- Other parameters meet general clinical trial enrollment criteria.
- The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.
- Patients with distant metastases other than supraclavicular lymph node metastases.
- Presence or high risk of esophageal perforation.
- Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.
- Patients who previously experienced unacceptable toxicity after receiving ICI therapy.
- Patients with a history of thoracoabdominal/pelvic radiotherapy within 6 months prior to enrollment.
- Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose no safety risk, such as fatigue or alopecia).
- people with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
- Respiratory depression, airway obstruction, or tissue hypoxia.
- Severe cardiac disease (i.e., NYHA functional class II or higher).
- Markedly abnormal liver or kidney function (i.e., indicators \>3 times the upper limit of normal).
- Active hepatitis B, hepatitis C, HIV, or syphilis.
- Active brain disease or central nervous system/meningeal metastases with significant symptoms, or impaired decision-making capacity.
- Hypersensitivity to drugs included in the trial.
- Drug and/or alcohol abuse.
- Pregnant or lactating women.
- Concurrent participation in another therapeutic clinical trial.
- Major surgical procedure within 30 days prior to enrollment.
- Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.
The study team makes the final eligibility decision.
Where it's taking place
- Shantou, Guangdong, 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 Shantou, Guangdong, 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.