ClinicalTrials.gg
RecruitingNCT04544969Updated Jan 28, 2025

Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

An observational study in Circulating Tumor Cell, Nasopharyngeal Carcinoma and Distant Metastases.Clinical, 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 2025-01-28.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Started Apr 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.

02

Conditions studied

  • Circulating Tumor Cell
  • Nasopharyngeal Carcinoma
  • Distant Metastases.Clinical
  • Effects of Chemotherapy
03

In context

Neoplastic Cells, Circulating

227 studies on the registry are indexed under Neoplastic Cells, Circulating; 54 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 121 observational studies indexed under Neoplastic Cells, Circulating.

Browse Neoplastic Cells, Circulating studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

NPC patients with distant metastasis after 3 months of primary radiotherapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • NPC patients with distant after 3 months of primary radiotherapy, and not suitable for local treatment
  • At least having one measurable metastatic lesion
  • All genders,range from 18~70 years old
  • score 0 \~ 1
  • Expected survival time ≥ 3 months
  • White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, (HGB) ≥ 90g/L, (PLT) count ≥ 100×109/L
  • (ALT) or aspartate aminotransferase(AST) \< 2.5×(ULN), (BUN) or creatinine(CRE) \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min
  • Inform consent form

Exclusion criteria

Exclusion Criteria:

  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts;
  • Mental disorder;
  • Pregnancy or lactation;
  • Severe complication, eg, uncontrolled hypertension.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Chemotherapy

    Patients treated with palliative chemotherapy

    Drug: cisplatin-based chemotherapy

Interventions

  • Drugcisplatin-based chemotherapy

    Drug pages: Docetaxel · Cisplatin

    GP: cisplatin 80 mg/m2 intravenous infusion on day1, gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8, both drugs are given every 3 weeks, recommended 6 cycles. TP: cisplatin 75 mg/m2 intravenous infusion in day1, docetaxel 75 mg/m2 intravenous infusion in day 1, both drugs are given every 3 weeks, recommended 6 cycles. PF: cisplatin 100 mg/m2 intravenous infusion in day1, fluorouracil 4000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. TPF: cisplatin 60 mg/m2 intravenous infusion in day1, docetaxel 60 mg/m2 intravenous infusion in day 1, fluorouracil 3000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. Choice of chemotherapy regimen is decided by patient's doctor in charge.

    Also known as: docetaxel and cisplatin, fluorouracil and cisplatin, docetaxel, fluorouracil and cisplatin, gemcitabine and cisplatin

06

What researchers measure

Primary outcomes

  1. The coincidence rate between drug sensitivity test in CTCs and objective response rate

    Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime

    Time frame: 6 months

Secondary outcomes

  1. The changes of CTCs countings

    Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

  2. Objective response rate

    To be determined by measurement of target lesions according to RECIST criteria

    Time frame: study period of 19 Months

  3. Progression free survival

    Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause.

    Time frame: baseline

  4. Cutoff value of CTC counts

    to identify patients with early relapse (\<6 months) after liver resection as determined by the AUC under the ROC curve

    Time frame: Objective response at 6 months

  5. Predictive value of the changes of CTCs countings

    Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04544969
Responsible party
Zhao Chong (Prof., Sun Yat-sen University) — Principal investigator
First posted
Sep 10, 2020
Start date
Apr 1, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 28, 2025

Study contacts

Jingjing Miao, M.D
Contact
miaojingjing90@163.com
86-13631355201
Chong Zhao, M.D
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion