Evaluating patient-reported outcomes in esophageal cancer treatment
Patient-reported Outcome-based Surveillance System Evaluating Safety and Efficacy of Preoperative Immunochemotherapy +/- Chemoradiation in Patients With Esophageal Squamous Cell Carcinoma - A Prospective, Explorative, Phase II Study
This study is testing if early relief from swallowing problems can help predict how well a new treatment combining immunotherapy and chemotherapy works for people with esophageal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05596890 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of patient-reported outcomes (PROs) to predict the effectiveness of preoperative immunochemotherapy and radiotherapy in patients with esophageal squamous cell carcinoma. It aims to determine if early relief of dysphagia can serve as a predictive biomarker for treatment response. The study will involve administering a combination of immune checkpoint inhibitors and chemotherapy, with or without short-term radiation, to assess both efficacy and safety. Participants will be closely monitored for their responses to treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed, potentially resectable esophageal squamous cell carcinoma who have not received prior treatment.
Not a fit: Patients with a history of thoracic surgery, previous cancers, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for esophageal cancer patients by identifying those who are likely to benefit from immunochemotherapy.
How similar studies have performed: While the use of PROs in cancer treatment is gaining traction, this specific approach in esophageal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed esophageal squamous cell carcinoma * Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0) * Treatment-naive * Expected life span \> 6 months * Aged 18 - 75 years old * Adequate organ functions * PS 0-2 * Participants are fully informed about the whole study and are willing to sign the informed consent Exclusion Criteria: * Previous history of thoracic surgery or radiation * Cervical or multi-origin esophageal cancer * Known or suspected experimental drug allergy * Pregnant or lactating women * Esophagomediastianl fistula * Peripheral neuropathy * Previous cancer history other than esophageal cancer * Severe organ function deterioration that can not tolerate neoadjuvant therapy * Previous autoimmune diseases * diabetic history \> 10 years * interstitial pulmonary disease, non-infectious pulmonitis * Active type B hepatitis * Any other conditions that may affect patients' safety and compliance
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Guibin Qiao, MD — Guangdong Provincial People's Hospital
- Study coordinator: Guibin Qiao, MD
- Email: guibinqiao@126.com
- Phone: 13602749153
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.