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An observational study of PD-1 inhibitor combined with chemoradiotherapy in the treatment of metastatic esophageal squamous cell carcinoma

A real world observational study of PD-1 inhibitor combined with chemoradiotherapy in the treatment of metastatic esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040533
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-03-08

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:Nil

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male or female; 2. Esophageal squamous cell carcinoma confirmed by pathology or histology is accompanied by distant metastasis at the first diagnosis or metastasis after surgery/radical chemoradiotherapy; 3. ECOG-PS score is 0-1, and the expected survival time is 3 months or more; 4. Accept PD-1 inhibitor combined with chemoradiotherapy; 5. At least one measurable lesion should be evaluated according to the RECISTv1.1 criteria; 6. Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years, except for basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ and breast cancer which have been effectively removed; 2. Previous treatment with CD137 agonist or immune checkpoint blocking therapy, including anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies; 3. Major surgical operation or unhealed wound, ulcer or fracture; 4. Patients who have received any previous radiotherapy treatment; 5. Allergy to drugs or any component in excipients; 6. History or evidence of interstitial lung disease or non-infectious pneumonia treated with corticosteroids (such as congenital pulmonary fibrosis, protracted pneumonia, drug-induced pneumonia, congenital pneumonia), or any active pneumonia detected on chest CT scan; 7. Patients with congenital or acquired immune deficiency (such as HIV-infected persons), active hepatitis B (HBV-DNA=104 copy number/mL) or hepatitis C (antibody positive for Hepatitis C and HCV-RNA higher than the lower limit for analysis), positive for tuberculosis, and inactive hepatitis B patients should take oral antiviral drugs simultaneously.

Design outcomes

Secondary

MeasureTime frame
Overall Survival;DOR;DCR;ORR;QoL;

Primary

MeasureTime frame
Progression-Free Survival;

Countries

China

Contacts

Public ContactChen Yongshun

Renmin Hospital of Wuhan University

yongshun2007@163.com+86 15327122084

Outcome results

None listed

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