Treatment for recurrent or metastatic squamous cell carcinoma of the head and neck
Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
This study is testing a new combination of three drugs to see if it can help people with advanced or returning squamous cell carcinoma of the head and neck feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03830385 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination treatment involving paclitaxel (albumin bound), bleomycin, and either cisplatin or carboplatin for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It is a single-arm, phase 2 trial that aims to provide insights into how well these drugs work together in this specific cancer population. The study focuses on patients who have advanced disease or have experienced recurrence after previous treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven stage IVc squamous cell carcinoma of the head and neck or recurrent disease after prior chemotherapy and/or radiotherapy.
Not a fit: Patients who are allergic to any of the study drugs or are currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced squamous cell carcinoma of the head and neck.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches using these drugs have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy proved squamous cell carcinoma of the head and neck; * stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy; * 18 years or older; without other malignancy; * proper functioning of the major organs. Exclusion Criteria: * allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ; * female within gestation period or lactation; * patients received drug of other clinical trial within 3 months
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, PhD
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
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.