Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT06886347

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2026-04-01

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.

Conditions

Metastatic Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W

Group Type: EXPERIMENTAL

Penplimab Injection

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Penplimab Injection

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.

Intervention Type: DRUG

Antitinib 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.

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Xiaozhong

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaozhong

chief physicians

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaozhong Chen, Doctor

Role: CONTACT

chenxz@zjcc.org.cn

0571-88128202

Facility Contacts

Xiaozhong Chen, Doctor

Role: primary

chenxz@zjcc.org.cn

0571-88128202

Other Identifiers

ALTN-AK105-Ib-02

Identifier Type: -

Identifier Source: org_study_id