Treatment for metastatic nasopharyngeal carcinoma using a combination of drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a treatment regimen that includes Penpulimab, Gemcitabine, and Anlotinib for patients with metastatic nasopharyngeal carcinoma. The primary endpoint of the study is progression-free survival, which measures the length of time during and after treatment that the patients live without the cancer worsening. Participants must meet specific eligibility criteria, including age, performance status, and prior treatment history. The trial aims to provide insights into a new therapeutic approach for this challenging cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaozhong Chen, Doctor
• Email: chenxz@zjcc.org.cn
• Phone: 0571-88128202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining penpulimab, anlotinib, and chemotherapy for esophageal cancer treatment

  This study is testing if a new combination of medications, including penpulimab and anlotinib, can improve treatment for people with advanced esophageal cancer before surgery.

  Recruiting Phase 2 Xijing Hospital · Xi'an, Shaan'xi · NCT06586242

• Combining Anlotinib and Penpulimab for Hepatocellular Carcinoma Treatment

  This study is testing if a new combination of two treatments can help prevent liver cancer from coming back in patients who are at high risk after surgery or other treatments.

  Recruiting at 47 sites Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Bengbu, Anhui and 66 other locations · NCT05862337

• Combination treatment for ctDNA positive gastric cancer

  This study is testing a new combination treatment for patients with a specific type of stomach cancer to see if it works better than the usual treatment.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT05494060

• Combination of Penpulimab and Chemotherapy for Advanced Esophageal Cancer

  This study is testing if adding Anlotinib to Penpulimab and chemotherapy can help people with advanced esophageal cancer feel better compared to just using Penpulimab and chemotherapy alone.

  Recruiting Phase 2 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT05214222

• Preoperative intensity-modulated radiotherapy with concurrent anlotinib for localized extremity and trunk soft tissue sarcoma

  This test combines preoperative IMRT and the drug anlotinib to see if it improves outcomes for adults with primary soft tissue sarcoma of the arms, legs, or trunk.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT05167994

• Zemetostat plus Anlotinib for SWI/SNF-deficient Head and Neck Soft Tissue Sarcoma

  This trial tests whether zemetostat plus anlotinib can help people with recurrent or metastatic head-and-neck soft tissue sarcoma that has SWI/SNF complex deficiency after standard therapy fails.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07917949

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.