Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial population

NPC patients with distant metastasis after 3 months of primary radiotherapy

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • cisplatin-based chemotherapy

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Chemotherapy1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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