RecruitingNCT03830385Updated Jul 16, 2019

Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

A Phase 2 interventional study of PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin in Squamous Cell Carcinoma Of The Head And Neck, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Feb 2021, 5 years 7 months ago, but the record still lists the study as recruiting.
Started Feb 2019; still recruiting 7 years 7 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 51
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck

Conditions studied

Squamous Cell Carcinoma Of The Head And Neck

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 51 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 51 participants (estimated)

Study arms

Experimental
Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or
Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin

Interventions

DrugPaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy

What researchers measure

Primary outcomes

overall survival
overall survival
Time frame: 5 years

Study locations

1 of 1 sites recruiting

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
- Zhihua Li, PhD · Contact
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03830385
Lead sponsor: Sun Yat-sen University
Responsible party: Qingqing Cai (Chief physician, Sun Yat-sen University) — Principal investigator
First posted: Feb 5, 2019
Start date: Feb 15, 2019
Primary completion: Feb 15, 2021 (estimated)
Completion: Feb 15, 2026 (estimated)
Last update: Jul 16, 2019

Study contacts

Qingqing Cai, PhD

Contact

caiqq@sysucc.org.cn

0086-20-87342823

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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