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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05978193
What this study is testing
What is Immunotherapy?
Immunotherapy is an investigational medicine, being studied as a potential treatment for esophageal squamous cell 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
- SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is 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 and older
You may be able to join if
- Age ≥18;
- Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
- ECOG performance status: 0-1 point;
- No prior anti-tumor treatment;
- Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.
You likely can't join if
- Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
- Patients who are potentially curable with surgery as assessed by investigators;
- Pleural metastasis or malignant pleural effusion, pericardial effusion;
- Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
- Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
See the full eligibility criteria
- Age ≥18;
- Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
- ECOG performance status: 0-1 point;
- No prior anti-tumor treatment;
- Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.
- Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
- Patients who are potentially curable with surgery as assessed by investigators;
- Pleural metastasis or malignant pleural effusion, pericardial effusion;
- Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
- Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
- Unstable cardiac diseases or symptoms;
- History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
- Active autoimmune disease or history of autoimmune disease;
- Conditions of immunodeficiency or active infection requiring systemic therapy;
- Pregnant or breastfeeding;
- Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
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 and older. 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.