Metastatic Nasopharyngeal Carcinoma

Phase 1

Recruiting

• Conditions: Metastatic Nasopharyngeal Carcinoma
• Interventions: Drug: Penplimab Injection; Drug: Antitinib Hydrochloride Capsules; Drug: Gemcitabine

• Registration Number: NCT06886347
• Lead Sponsor: Chen Xiaozhong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Study First Submitted: 2023-07-11
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. The participants voluntarily signed an informed consent form.
2. Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. xpected survival of ≥ 3 months.
5. Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
6. Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
7. At least one measurable tumor lesion per RECIST 1.1 criteria.
8. Adequate organ function.
9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study.
10. The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.

Exclusion Criteria

1. 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.
2. Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
3. 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.
4. 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).
5. Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
6. Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.
7. Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
8. Previously received anti angiogenic therapy.
9. According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Penplimab Injection	Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W
Experimental group	Antitinib Hydrochloride Capsules	Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W
Experimental group	Gemcitabine	Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W

Primary Outcome Measures

Name	Time	Method
PFS	Baseline up to 2 years	PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Baseline up to 2 years	Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
Overall survival (OS)	Baseline up to 2 years	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 to Response (TTR)	Baseline up to 2 years	TTR defined as the time from randomization to the first recorded CR or PR
Duration of Response (DOR)	Baseline up to 2 years	DOR defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
PD-L1 expression	Tumor tissue samples must be provided to the research center prior to initial administration	Evaluating the correlation between PD-L1 expression and efficacy in tumor tissue samples.
Blood EBV level	Baseline up to 2 years	Evaluate the correlation between the copy number of EBV DNA in the blood of subjects and their efficacy.
Evaluate the health-related quality of life (HRQoL) of subjects	Baseline up to 2 years	Evaluate the health-related quality of life (HRQoL) of subjects using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scale。The minimum values is 1，the maximum values is 4，and whether higher scores mean a worse outcome.
Objective Response Rate（ORR）	Baseline up to 2 years	Percentage of subjects achieving complete response (CR) and partial response (PR)

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China