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

NCT ID: NCT05854849

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2027-12-01

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAP

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

200mg, D1, Q3W, iv drip.

Gemcitabine

Intervention Type: DRUG

1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.

Apatinib

Intervention Type: DRUG

250mg, PO, QD

GPP

Group Type: ACTIVE_COMPARATOR

Camrelizumab

Intervention Type: DRUG

200mg, D1, Q3W, iv drip.

Gemcitabine

Intervention Type: DRUG

1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.

Cisplatin

Intervention Type: DRUG

80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.

Interventions

Camrelizumab

200mg, D1, Q3W, iv drip.

Intervention Type: DRUG

Gemcitabine

1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.

Intervention Type: DRUG

Cisplatin

80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.

Intervention Type: DRUG

Apatinib

250mg, PO, QD

Intervention Type: DRUG

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.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ming-Yuan Chen, MD,PhD

Role: primary

chmingy@mail.sysu.edu.cn

86-20-8734-2422

Rui You, MD,PhD

Role: backup

yourui@sysucc.org.cn

+8613580439820

Other Identifiers

SYSUCC-CMY-2023-GAPvsGPP

Identifier Type: -

Identifier Source: org_study_id