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Tests treatment safety and results for Esophageal Squamous Cell Carcinoma
Official title Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06885814
What this study is testing
What is Adebrelimab: 20mg/kg day1, Q3W, 3 times?
Adebrelimab: 20mg/kg day1, Q3W, 3 times is an investigational medicine, given as an once-weekly infusion into a vein, 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
- This study was a single-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy.
- 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
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor how well it works evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not...
- ECOG: 0\~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL...
You likely can't join if
- Other malignant tumors have been diagnosed within the previous 5 years
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
See the full eligibility criteria
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor how well it works evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
- ECOG: 0\~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN 7: people voluntarily...
- Other malignant tumors have been diagnosed within the previous 5 years
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Patients with immune dysfunction and active hepatitis
- Those who have previously received PD-1 or PD-L1 antibody therapy
- Allergic to any drug in this protocol
- Patients receiving immunosuppressive drugs or corticosteroids \>10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
- Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 Guangzhou, 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.