BridgeMD
New treatment option for Metastatic Esophageal Squamous Cell Carcinoma
Official title A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
ClinicalTrials.gov ID: NCT05760391
What this study is testing
- What it's testing
- This study is a single-arm, prospective, phase II trial for patients with metastatic esophageal squamous cell carcinoma (ESCC) who received immunotherapy plus chemotherapy as the first-line treatment. The aim of the study is to determine if intervening with combined local therapy and immunotherapy and chemotherapy in patients with ESCC led to significant improvements in survival and disease control compared with historical data.
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 80
You may be able to join if
- Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1;
- Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant...
- Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation...
- Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment.
- All lesions of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment.
You likely can't join if
- Patients who are prior exposure to immune-mediated therapy.
- Patients participated in any investigational drug study within 4 weeks preceding the start of treatment.
- The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)...
- Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms.
- Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.
- Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this...
See the full eligibility criteria
- Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1;
- Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease;
- Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible);
- Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment.
- All lesions of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment.
- The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is...
- Estimated survival time \>12 weeks.
- The function of vital organs meets the following requirements: Neutrophil absolute count (ANC) ≥ 1.5 × 10\^9 / L platelets ≥ 100 × 10\^9 / L; Hemoglobin ≥ 9g / dL; serum albumin ≥ 2.8g / dL; Total bilirubin ≤ 1.5 × ULN...
- Female people of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. people agreed to adequate contraception during the trial.
- The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative.
- Patients who are prior exposure to immune-mediated therapy.
- Patients participated in any investigational drug study within 4 weeks preceding the start of treatment.
- The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 level 1 (except for hair loss) or the level specified by the...
- Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms.
- Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.
- Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this study.
- Any other malignant tumor was diagnosed within 5 years prior to or after the diagnosis of ESCC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate \>90%), such as well-treated...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.