Health TrialsbyHealthPanel

Metastatic Nasopharyngeal Carcinoma

ConditionMetastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaozhong

About this trial

To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participants voluntarily signed an informed consent form.

Age of ≥ 18 years and ≤ 75 years at the time of enrollment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

xpected survival of ≥ 3 months.

Disqualifiers

ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.

Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.

Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.

Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).

Trial design

Design model

Single group

Treatments tested in this trial

  • Penplimab Injection

    Drug

    Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

  • Antitinib Hydrochloride Capsules

    Drug

    10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.

  • Gemcitabine

    Drug

    Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

Treatment groups

47 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PFS

PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.

Time frame
Baseline up to 2 years

Secondary outcomes

1

Objective Response Rate（ORR）

Percentage of subjects achieving complete response (CR) and partial response (PR)

Time frame
Baseline up to 2 years
2

Disease Control Rate (DCR)

Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)

Time frame
Baseline up to 2 years
3

Overall survival (OS)

OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up

Time frame
Baseline up to 2 years
4

Time to Response (TTR)

TTR defined as the time from randomization to the first recorded CR or PR

Time frame
Baseline up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chen Xiaozhong

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now