Actively Recruiting
Phase II Study of Sintilimab with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Led by Shanghai Chest Hospital · Updated on 2024-11-29
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC), specifically those who are treatment-nafve and have certain stages of the disease including cT4bN-/+M0 and/or cTanyN+M0, which may involve extracapsular invasion of mediastinal lymph nodes. The study is a phase II, single-arm trial evaluating the effectiveness and safety of combining sintilimab with chemotherapy followed by sequential concurrent chemoradiotherapy as a conversion therapy approach for this patient group. Participants will first receive two cycles of sintilimab combined with liposomal paclitaxel and cisplatin chemotherapy. After this, an evaluation will determine if surgery is possible. If surgery is feasible, patients undergo resection followed by up to one year of adjuvant sintilimab, with possible postoperative radiotherapy as decided by the investigator. Patients ineligible for surgery will receive concurrent chemoradiotherapy with a total radiation dose of 5040cGy in 28 fractions, after which a second surgical evaluation is done. Those then eligible for surgery will have resection and continue sintilimab, while those remaining ineligible will continue sintilimab treatment after chemoradiotherapy. During the study, participants will have regular assessments including imaging and clinical evaluations to monitor treatment response and safety. Researchers will measure outcomes such as the 2-year overall survival rate, resection rates, pathological complete response, major pathological response, event-free survival, and surgical conversion rates. Participants will be followed for up to 24 months to evaluate these outcomes and monitor any treatment-related effects or adverse events throughout the study period.
CONDITIONS
Brief Title
A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age between 20 and 75 years, any gender
- Diagnosed with esophageal squamous cell carcinoma (ESCC) at cT4bN-/+M0 and/or cTanyN+M0 stage
- Tumor located in the thoracic esophagus
- Primary lesion inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes
- ECOG performance status of 0 or 1
- Estimated survival time of at least 6 months
- No prior antitumor therapy for esophageal cancer
- At least one measurable lesion per RECIST 1.1 criteria
- No surgical contraindications based on organ function evaluation
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within three days before first dose
- Participants of childbearing potential must use highly effective contraception during the study and for specified periods after treatment
You will not qualify if you...
- Diagnosis of other malignancies within 5 years prior to first dose, except certain treated skin or cervix cancers
- Presence or high risk of tracheoesophageal or aortoesophageal fistulas
- Presence of distant metastases
- Participation in another interventional study or use of investigational drugs/devices within 4 weeks prior to first dose
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, CTLA-4, OX-40, or CD137
- Use of systemic traditional Chinese medicine or immunomodulatory drugs within 2 weeks prior to first dose, except local use for pleural effusion
- Active autoimmune disease needing systemic therapy within 2 years prior to first dose
- Use of systemic corticosteroids or immunosuppressants within 7 days prior to first dose, except low physiological doses
- History of allogeneic organ or stem cell transplantation
- Known allergy to study drug components
- Incomplete recovery from prior therapy toxicities
- HIV infection
- Untreated active hepatitis B or C infection
- Live vaccines within 30 days prior to first dose, except inactivated influenza vaccine
- Pregnant or breastfeeding women
- Recent gastrointestinal bleeding or coagulation disorders
- Severe uncontrolled systemic diseases including serious heart conditions, recent arterial thrombosis, uncontrolled blood pressure, lung diseases, active infections, liver diseases, poorly controlled diabetes, significant proteinuria, or psychiatric disorders
- Any condition that may interfere with study participation or outcomes as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies based on treatment response and surgery eligibility
Participants receive two cycles of sintilimab combined with chemotherapy. After evaluation, those eligible undergo surgical resection followed by up to one year of adjuvant sintilimab. Those ineligible for surgery receive concurrent chemoradiotherapy, followed by a second surgical evaluation. Depending on eligibility, participants may undergo surgery followed by adjuvant sintilimab or continue sintilimab after chemoradiotherapy.
Multiple visits during cycles and evaluations, including weekly visits during chemoradiotherapy
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
J
Jun Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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