Combining anti-PD-1 therapy with targeted radiation for esophageal cancer patients
Phase 2 Study of Anti-PD-1 Immunotherapy Combined With Stereotactic Body Radiation Therapy for Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
This study is testing whether combining a new immune therapy with targeted radiation can help people with advanced esophageal cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05626569 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness and safety of combining anti-PD-1 immunotherapy with stereotactic body radiation therapy (SBRT) for patients suffering from oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD-1 treatment followed by SBRT targeting metastatic lesions after completing 4 to 6 cycles of standard chemotherapy. The study aims to assess how this combination therapy can improve patient outcomes in managing their cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed esophageal squamous cell carcinoma, stage IVB disease, and less than five metastatic lesions who have not experienced disease progression after initial chemotherapy.
Not a fit: Patients with more than five metastatic lesions or those who have not responded to prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with oligometastatic esophageal cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and targeted radiation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group performance status ≤ 2; 2. Histologically confirmed squamous cell carcinoma of the esophagus; 3. Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than five metastatic lesions within three organs; 4. Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease was confirmed; 5. At least one metastatic lesions amenable to the delivery of SBRT; 6. Estimated life expectancy \>4 months; 7. The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min; 8. Ability to understand the study and sign informed consent. Exclusion Criteria: 1. Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment; 2. Patients with intracranial metastasis disease at diagnosis; 3. History of thoracic irradiation; 4. Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum; 5. Patients have spinal bone metastases combined with spinal cord compression; 6. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer; 7. Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia; 8. Inability to provide informed consent due to psychological, familial, social, and other factors; 9. Female patients who are pregnant or during lactation; 10. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; 11. A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).
Where this trial is running
Guangzhou, Guangdong
- Mian Xi — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Mian Xi, MD — Sun Yat-sen University
- Study coordinator: Mian Xi, MD
- Email: ximian@sysucc.org.cn
- Phone: 02087340540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.