NCT06173986RecruitingPhase 1/2
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
A Phase I/II Multicenter Study Evaluating the Efficacy and Safety of Induction Immunochemotherapy Followed by Concurrent Immuno-Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Cancer(SCR-ESCC-02)
Source: ClinicalTrials.gov · Last updated 18 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- 10 Jan 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06173986
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 10 Jan 2023 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
Other illness
- 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.
- 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
- History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
- Allergy to study drugs.
Other
- Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.