Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC

Trial Title: Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC

NCT ID: NCT05854849

Condition: Nasopharyngeal Carcinoma

Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Apatinib

Conditions: Keywords:
Nasopharyngeal Carcinoma
PD-1
metastatic

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab
Description: 200mg, D1, Q3W, iv drip.
Arm group label: GAP
Arm group label: GPP

Intervention type: Drug
Intervention name: Gemcitabine
Description: 1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.
Arm group label: GAP
Arm group label: GPP

Intervention type: Drug
Intervention name: Cisplatin
Description: 80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.
Arm group label: GPP

Intervention type: Drug
Intervention name: Apatinib
Description: 250mg, PO, QD
Arm group label: GAP

Summary: This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Male or female; 18-70 years of age; 2. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent lesion unfit for local treatment). 3. Did not receive any systemic treatment for recurrent and metastatic lesions. (Previous radiotherapy, induction chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy should have been completed at least 6 months prior to treatment) 4. ECOG performance status of 0 or 1. 5. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1. 6. Adequate organ function assessed by laboratory parameters during the screening period 7. Life expectancy more than 12 weeks. 8. Able to understand and sign an informed consent form (ICF). Exclusion Criteria: 1. Patients with a high risk of nasopharyngeal necrosis: ① Patients with recurrent stage T3-4 received two courses of radiotherapy before enrollment, or received nasopharyngeal radiotherapy within 1 year before enrollment; ② Patients with recurrent T1-2 stage had received two courses of nasopharyngeal radiotherapy and the last radiotherapy within 1 year before enrollment. 2. Patients with other malignancies (except for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, and ductal carcinoma in situ who have undergone curative treatment). 3. Special attention: Patients with active bleeding, ulcers, bowel perforations, and major surgery within 30 days; tumors in close proximity to the internal carotid artery or other major vessels, and those at risk of major bleeding. Patients with or previous with serious hemorrhage (bleeding >30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack). 4. Patients with hypertension who cannot be reduced to the normal range by antihypertensive drug treatment (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg), patients with ≥ grade II coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency. 5. Patients with known or suspected autoimmune diseases including dementia and seizures. 6. Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction). 7. An excessive dose of glucocorticoids given within 4 weeks before enrollment. 8. Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids. 9. HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive). 10. Women of childbearing age with a positive pregnancy test and lactating women.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Ming-Yuan Chen, MD,PhD

Phone: 86-20-8734-2422
Email: chmingy@mail.sysu.edu.cn

Contact backup:
Last name: Rui You, MD,PhD

Phone: +8613580439820
Email: yourui@sysucc.org.cn

Start date: May 1, 2023

Completion date: December 1, 2027

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05854849