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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
ClinicalTrials.gov ID: NCT06173986
What this study is testing
What is PD-1inhibitor?
PD-1inhibitor is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as Immunotherapy.
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-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.
- 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 between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
- Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for...
- No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
You likely can't join if
- History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
- Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
- Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug...
- Presence of any severe or uncontrolled coexisting diseases, including but not limited to:
- Uncontrolled hypertension
See the full eligibility criteria
- Age between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
- Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
- No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
- Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
- Willingness to use contraception with an adequate method throughout the study.
- Documented informed consent.
- History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
- Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
- Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
- Presence of any severe or uncontrolled coexisting diseases, including but not limited to:
- Uncontrolled hypertension
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or C, syphilis, or other active and uncontrolled infections
- Cardiac insufficiency (NYHA≥2)
- Renal dysfunction requiring dialysis
- Active autoimmune disease
- History of acquired or congenital immunodeficiency diseases
- Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
- History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
- Allergy to study drugs.
- Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
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 75 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.