Circulating Tumor CellNCT04544969
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC
An observational study of Circulating Tumor Cell and Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Circulating Tumor Cell, Nasopharyngeal Carcinoma, Distant Metastases.Clinical
- What is being tested?
- cisplatin-based chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: NPC patients with distant metastasis after 3 months of primary radiotherapy
Who may be able to join
- NPC patients with distant metastasis 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
- ECOG score 0 ~ 1
- Expected survival time ≥ 3 months
- White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L
- Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) < 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min
- Inform consent form
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Chong Zhao, 02087342638, zhaochong@sysucc.org.cn
About this study
Official title: Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
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.
- Conditions
- Circulating Tumor Cell, Nasopharyngeal Carcinoma, Distant Metastases.Clinical, Effects of Chemotherapy
- Being tested
- cisplatin-based chemotherapy
- Medical subject headings
- Neoplastic Cells, Circulating, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin-based chemotherapyDrug
Also called docetaxel and cisplatin, fluorouracil and cisplatin, docetaxel, fluorouracil and cisplatin, gemcitabine and 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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Patients treated with palliative chemotherapy Receives: Drug: cisplatin-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
The changes of CTCs countings
Measured: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Objective response rate
To be determined by measurement of target lesions according to RECIST criteria
Measured: study period of 19 Months
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.
Measured: baseline
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
Measured: Objective response at 6 months
Predictive value of the changes of CTCs countings
Measured: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- Chong Zhao, M.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544969
- Sponsor's protocol ID
- B2019-128
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2020
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT04544969
- Acronym / sponsor ID
- B2019-128
- Conditions
- Circulating Tumor Cell, Nasopharyngeal Carcinoma, Distant Metastases.Clinical, Effects of Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Drug: cisplatin-based chemotherapyPatients treated with palliative chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NPC patients with distant metastasis after 3 months of primary radiotherapy
Key inclusion criteria (8 listed)
- NPC patients with distant metastasis 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
- ECOG score 0 ~ 1
- Expected survival time ≥ 3 months
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin-based chemotherapyAlso: docetaxel and cisplatin, fluorouracil and cisplatin, docetaxel, fluorouracil and cisplatin, gemcitabine and cisplatinGP: 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. | Drug | Chemotherapy |
Primary outcome
The coincidence rate between drug sensitivity test in CTCs and objective response rate
Time frame: 6 months
Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime
5 secondary outcomes
The changes of CTCs countings
Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Objective response rate
Time frame: study period of 19 Months
Progression free survival
Time frame: baseline
Cutoff value of CTC counts
Time frame: Objective response at 6 months
Predictive value of the changes of CTCs countings
Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chong Zhao, M.D principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cell and Nasopharyngeal Carcinoma, 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Miao, M.D (86-13631355201, miaojingjing90@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coincidence rate between drug sensitivity test in CTCs and objective response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025.