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Radiotherapy combined with pembrolizumab in the treatment of esophageal cancer patients with oligometastasis after radical treatment: a prospective, open, single-arm phase II clinical study

Radiotherapy combined with pembrolizumab in the treatment of esophageal cancer patients with oligometastasis after radical treatment: a prospective, open, single-arm phase II clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045015
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

esophageal squamous cell carcinoma

Interventions

Treatment group:Radiotherapy combined with Pembrolizumab

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-80 years; 2.Esophageal squamous cell carcinoma (ESCC) diagnosed by pathology and imaging at the first diagnosis; 3.Metastatic oligometastasis occurred after receiving radical treatment in the past, and the interval between first diagnosis and oligometastasis is greater than or equal to 6 months; 4.The imaging evaluation is less than or equal to 5 oligometastatic lesions, less than or equal to two oligometastatic organs, and a single organ has less than or equal to 3 metastatic lesions; 5.Unable to perform surgical treatment on metastatic lesions due to iatrogenic or (and) personal factors; 6.Satisfactory control of primary disease; 7.All metastatic tumors can be treated with IMRT; 8.ECOG physical status score: 0-1 points, Karnofsky score >= 60, able to tolerate radiotherapy; 9.The estimated survival period is >= 3 months; 10.Sign the informed consent form; 11.The compliance is good, and the family members agree to cooperate with the survival follow-up.

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Allogeneic organ transplantation or allogeneic bone marrow transplantation; 3.Immune system diseases such as Crohn's disease, ulcerative colitis, lupus erythematosus, etc.; 4.A known history of human immunodeficiency virus (HIV) positive test or known acquired immunodeficiency syndrome (AIDS); 5.Severe heart, lung, kidney, and liver diseases; 6.The active period of viral hepatitis; 7.According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study; 8.Severe hypertension, diabetes mellitus.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactLi Jie

Mianyang Central Hospital

lijie.718@163.com+86 15228324561

Outcome results

None listed

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