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A real-world clinical study of the resectable esophageal carcinoma neoadjuvant treated with Camrellizumab

A real-world clinical study of the resectable esophageal carcinoma neoadjuvant treated with Camrellizumab

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039170
Enrollment
Unknown
Registered
2020-10-20
Start date
2020-10-20
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus cancer

Interventions

Case series:Nil

Sponsors

Quanzhou First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with surgically resectable esophageal cancer confirmed by pathology (including histology or cytology) (according to CSCO guidelines for diagnosis and treatment of esophageal cancer in 2020); 3. Patients with at least one measurable lesion (RECIST Standard Version 1.1); 4. ECoG PS: 0-1; 5. Patients with an estimated survival time of more than 3 months; 6. The blood routine, blood biochemistry and coagulation function of the subjects with normal main organ function were basically normal; 7. Women of childbearing age should have pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative. Male subjects and women of childbearing age were required to use contraception within 24 weeks from the beginning of the first dose of the study drug to the end of the study drug.

Exclusion criteria

Exclusion criteria: 1. Patients with active, known or suspected autoimmune diseases; 2. Subjects with severe infection within 4 weeks before the first medication, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. 3. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA grade 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 24 weeks; (4) Supraventricular or ventricular arrhythmias with clinical significance need treatment or intervention. 4. Patients with interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5. The subjects had active hepatitis B (HBV DNA >= 2000 IU / ml or 104 copies / ml) and hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit); 6. Patients with allergic reactions to the drugs used in this study; 7. Pregnant or lactating women; 8. According to the judgment of the researcher, there are other factors that may lead to the termination of the study.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
Major pathological remission;RO resection;Complete pathological remission;1 year overall survival rate;

Countries

China

Contacts

Public ContactRongyu Xu, Yi Zhang

Quanzhou First Hospital

xry641127@sina.com+86 13805929956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026