Combining chemoradiation with QL1706 for esophageal cancer treatment
A Single Arm, Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
PHASE2 · Tianjin Medical University Cancer Institute and Hospital · NCT05490719
This study is testing if adding a new antibody treatment to standard chemoradiation can help people with advanced esophageal cancer who can't have surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (other) |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05490719 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the safety and efficacy of combining chemoradiation therapy with QL1706, an anti-CTLA-4 and PD-1 antibody, in patients with unresectable locally advanced esophageal squamous cell carcinoma. It is a single-arm, multi-center study aimed at patients who have not undergone surgery for their cancer. The trial will assess the treatment's effectiveness based on measurable tumor responses and safety profiles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed unresectable locally advanced esophageal squamous cell carcinoma.
Not a fit: Patients who have undergone surgery for esophageal cancer or have significant complications such as gastrointestinal bleeding or fistulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced esophageal cancer who currently have limited treatment choices.
How similar studies have performed: While this approach combines established therapies with immunotherapy, the specific combination of QL1706 with chemoradiation in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects participate voluntarily and sign informed consent. 2. age:18-75 years, male or female. 3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0. 4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: 1. Patients who have a history of esophageal cancer surgery. 2. Previous history of fistula caused by primary tumor infiltration. 3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation. 4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention. 5. Major surgery or serious trauma within 4 weeks before the first use of the study drug.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin cancer hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Qingsong Pang
- Email: pangqingsong2013@163.com
- Phone: 0862223340123
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.
Conditions: Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706