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A single-arm, prospective, multicenter, exploratory clinical study of radiotherapy sequential Camrelizumab in elderly patients with locally advanced esophageal cancer

A single-arm, prospective, multicenter, exploratory clinical study of radiotherapy sequential Camrelizumab in elderly patients with locally advanced esophageal cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033622
Enrollment
Unknown
Registered
2020-06-07
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

esophageal cancer

Interventions

case series:radiotherapy sequential Camrelizumab

Sponsors

Second Affiliated Hospital of Suzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who voluntarily participate in and sign the informed consent in writing; 2. Aged >=65 years; 3. Patients with esophageal cancer confirmed by histology or cytologyLocal; 4. Patients with locally advanced esophageal cancer who can not/Unwilling to excise or can not tolerate chemotherapy; 5. ECoG 0-1 (see attachment 2 for ECoG scoring standard); 6. Patients with expected survival >=3 months; 7. Patients with less severe hematopoiesis, heart, lung, liver and kidney dysfunction and immune deficiency; Neutrophils >=1.5x10^9/L; hemoglobin >= 9g/dl; platelets >=100 x 10^9/L; total bilirubin <=1.5 ULN; ast (SGOT) and ALT (SGPT) <= 2.5 ULN; creatinine <=1.5 ULN.

Exclusion criteria

Exclusion criteria: 1. Patients with esophageal perforation or hematemesis; 2. Patients with any active autoimmune disease or a history of autoimmune disease (such as interstitial Pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy is effective), and have a history of using immunosuppressant within 28 days, but for the treatment of radiotherapy and chemotherapy Except for toxic hormones; 3. Patients with more than level 2 adverse events not recovered (i.e. level 1 or baseline level) caused by the treatment received before the first use of the study drug. According to the judgment of researchers, adverse events (such as neurotoxicity) that are difficult to recover quickly can be included in the group; 4. Those patients who were judged by the researchers to have non infectious pneumonia caused by previous radiotherapy and chemotherapy; 5. Patients who have received or are receiving other PD-1 antibody treatment or other immunotherapy for PD-1 / PD-L1; 6. Patients who are known to be allergic to macromolecular protein preparations, or to any of the components of carrizumab (shr-1210) and its preparations; 7. Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Patients with congenital or acquired immune deficiency (such as HIV infected patients), active hepatitis B (HBV-DNA >=10^4 copies / ml) or hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or active tuberculosis; 9. Patients with active infection or fever with unknown cause more than 38.5 degrees C within 2 weeks before randomization (according to the judgment of the researcher, the fever of the subject due to tumor can be included in group); 10. The fertile male or female is unwilling to take contraceptive measures in the test, and the female patient is pregnant or lactating; 11. According to the researcher's judgment, there are other factors that may cause him / her to be forced to terminate the study midway, such as other serious diseases (including mental diseases) requiring combined treatment, family or social factors, which may affect the safety of the subject or the collection of experimental data.

Design outcomes

Secondary

MeasureTime frame
PFS;DCR;ORR;

Primary

MeasureTime frame
OS;

Countries

China

Contacts

Public ContactZhu Yaqun

Second Affiliated Hospital of Suzhou University

szzhuyaqun@sina.com+86 13004586267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026