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Nasopharyngeal CancerPhase 1NCT04850235

Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study

A Phase 1 study testing Nab paclitaxel in people with Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Cancer
What is being tested?
Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
15 Apr 2021to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
  • Original clinical staged as III-IVa （according to the 8th AJCC edition).
  • No evidence of distant metastasis (M0).
  • Male and no pregnant female.
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
  • WBC ≥ 4×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L.
  • With normal liver function test (ALT/AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN).
  • With normal renal function test (Creatinine Clearance ≥ 60 ml/min ).

Who cannot join

  • Patients have evidence of relapse or distant metastasis.
  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
  • Receiving radiotherapy or chemotherapy previously.
  • The presence of uncontrolled life-threatening illness.
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Receiving other ways of anti-cancer therapy.
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Nab-paclitaxel Plus Cisplatin and Capecitabine as Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase I Dose-escalation Study

Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Capecitabine is the precursor drug of 5-fluorouracil, and has been used in replace of 5-fluorouracil in NPC patients. Nab-paclitaxel (Nab-PTX) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel. We sought to find out the efficacy of Nab-PTX in three-drug triplet (Nab-PTX, DDP and capecitabine) and decide the best administration dose of Nab-PTX.

Read the detailed description

Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Capecitabine is the precursor drug of 5-fluorouracil, and has been used in replace of 5-fluorouracil in NPC patients. Nab-paclitaxel (Nab-PTX) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel. It was developed to reduce toxicities associated with paclitaxel whilst maintaining or improving its chemotherapeutic effect. In vivo preclinical experiments have shown greater volume of distribution of nab-paclitaxel than paclitaxel, with similar half-life and clearance. The efficacy and optimal dose of Nab-PTX combined with DDP as doublet has been explored in metastatic NPC patients and locoregionally advanced patients, and it showed encouraging anti-tumor effects and manageable toxicities. However, what is the optimal dose of Nab-PTX and the efficacy of it in three-drug triplet (Nab-PTX, DDP and capecitabine) needs to be discovered. Therefore, this study aims to evaluate the efficacy and safety of Nab-PTX plus cisplatin and capecitabine neoadjuvant chemotherapy, followed by cisplatin-based concurrent chemoradiotherapy in the patients with locoregionally advanced nasopharyngeal carcinoma, to provide new evidence for the use of Nab-PTX in NPC.

Being tested
Nab paclitaxel
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab paclitaxelDrug

    Nab paclitaxel plus cisplatin and capecitabine as neoadjuvant chemotherapy

Study groups in NCT04850235
Study groupRoleWhat they receive
TPX neoadjuvant chemotherapy +CCRTExperimentalPatients receive neoadjuvant chemotherapy with Nab-PTX (150/175/200/225/250 mg/m2, D1) , cisplatin (75 mg/m2, D1) and capecitabine (1000 mg/m2, BID, D1-14) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100 mg/m2) concurrent every three weeks during radiotherapy (D1, D22, D43 of RT)
Receives: Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    If more than one-third of patients in a given cohort experienced a dose-limiting toxicity (DLT), enrollment will be stopped and the dose used in the previous cohort will be designated as the maximum tolerated dose

    Measured: At the end of each cycle (each cycle is 21 days)

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence rate of adverse events (AEs), evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria.

    Measured: At the end of each cycle (each cycle is 21 days)

Secondary outcomes (4)

  1. Objective response rate

    The proportion of patients whose tumors shrink to a certain size and maintain such size for a certain period of time, including patients with complete response (CR) and partial response (PR).

    Measured: 3 months

  2. Disease control rate

    The proportion of patients with response and stable disease (SD) after treatment, including patients with CR, PR and SD.

    Measured: 3 months

  3. Overall survival

    Overall survival is calculated from the date of enrollment to the date of the death from any cause or censored at the date of the last follow-up.

    Measured: 2-year

  4. Progression-free survival

    Progress-free survival is calculated from the date of enrollment to the date of the first progression at any site or death from any cause or censored at the date of the last follow-up.

    Measured: 2-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start15 Apr 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04850235
Sponsor's protocol ID
2020-FXY-489
Status last verified
Jun 2023
First submitted
12 Apr 2021
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yu-Chen, Luo MJ, Liu RP, Jin J, Deng SW, Tang LQ, Li XY, Liu LT, Luo DH, Sun R, Liu SL, Li JB, Liu Q, Wang P, Chen QY, Mai HQ, Guo SS. Phase I dose-escalation study of nab-paclitaxel combined with cisplatin and capecitabin as induction chemotherapy followed by concurrent chemoradiotherapy in patients with nasopharyngeal carcinoma. Radiother Oncol. 2024 Feb;191:110051. doi: 10.1016/j.radonc.2023.110051. Epub 2023 Dec 21.

    PubMed 38135184

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nab paclitaxel in people with Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: At the end of each cycle (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04850235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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