Testing a new treatment approach for advanced esophageal cancer
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
This study is testing a new treatment approach for people with advanced esophageal cancer to see if a combination of chemotherapy and radiation can help them feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06020885 on ClinicalTrials.gov |
What this trial studies
This Phase I study aims to determine the maximum tolerated fraction dose of split-course hypofractionated concurrent chemoradiotherapy (hypo-CCRT) following induction chemo-immunotherapy in patients with unresectable locally advanced esophageal squamous carcinoma (LA-ESCC). The study will evaluate the dosimetric advantages of this treatment regimen and assess treatment-related toxicities and the quality of life of participants. By focusing on a novel combination of therapies, the study seeks to improve outcomes for patients who have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed esophageal squamous cell carcinoma at stages II-IVB who have not undergone prior malignancies and meet specific health criteria.
Not a fit: Patients with contraindications for radiotherapy or chemotherapy, or those with distant metastasis beyond specified lymph nodes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and reduce side effects for patients with advanced esophageal cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving treatment outcomes for advanced cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed ESCC * II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002) * Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 * Charlson Comorbidity Index score≤4 * oral medication can be administered despite esophageal obstruction * adequate hematological, renal and hepatic functions Exclusion Criteria: * contraindication for radiotherapy or chemotherapy * prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ * distant metastasis, except for celiac or supraclavicular lymph nodes metastases
Where this trial is running
Guangzhou, Guangdong
- Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hui Liu, Professor — Sun yat-sen universtiy cancer center
- Study coordinator: Bo Qiu, Professor
- Email: qiubo@sysucc.org.cn
- Phone: +86-020-87343031
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.