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New treatment option for Toripalimab
Official title Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07086469
What this study is testing
What is Neoadjuvant immunochemotherapy?
Neoadjuvant immunochemotherapy is an investigational medicine, being studied as a potential treatment for toripalimab.
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
- The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.
- 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 80
You may be able to join if
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
- Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced...
- Male or female patients aged 18 to 80 years.
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.
- Expected life expectancy of at least 12 weeks.
You likely can't join if
- Participation in another clinical trial simultaneously, except for observational (non-treatment) studies.
- Prior use of any targeted therapy.
- Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).
- Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled...
- Performance status (PS) score of 2-4.
- Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \ 1.5 × upper limit of normal...
See the full eligibility criteria
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
- Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower...
- Male or female patients aged 18 to 80 years.
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.
- Expected life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine...
- Signed and dated informed consent form must be obtained prior to any study-related procedures.
- Participation in another clinical trial simultaneously, except for observational (non-treatment) studies.
- Prior use of any targeted therapy.
- Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).
- Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or...
- Performance status (PS) score of 2-4.
- Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)...
- Any condition that may interfere with the assessment of how well it works or safety of surufatinib.
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 80 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.