Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Recruiting
Phase 1Phase 2Interventional Study
Esophageal Squamous Cell CarcinomaUnresectable Locally Advanced Esophageal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Shanghai Chest Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Age between 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
4. Ineligibility for surgical resections due to patients' unwillingne…
Inclusion Criteria:
1. Age between 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
7. Willingness to use contraception with an adequate method throughout the study.
8. Documented informed consent.
Exclusion Criteria:
1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
5. 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
6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
8. Allergy to study drugs.
9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.