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Efficacy and safety of induction chemotherapy of albumin-bound paclitaxel, cisplatin and capecitabine and sequential concurrent chemoradiotherapy combined with apatinib and camrelizumab for stage N3M0 nasopharyngeal carcinoma: a prospective, single-arm, open labeled phase II clinical trial

Efficacy and safety of induction chemotherapy of albumin-bound paclitaxel, cisplatin and capecitabine and sequential concurrent chemoradiotherapy combined with apatinib and camrelizumab for stage N3M0 nasopharyngeal carcinoma: a prospective, open labeled phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032317
Enrollment
Unknown
Registered
2020-04-25
Start date
2020-05-01
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Case series:induction chemotherapy of albumin-bound paclitaxel, cisplatin and capecitabine and sequential concurrent chemoradiotherapy combined with apatinib and camrelizumab

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed WHO type II or III NPC; 2. Primary treatment of patients without anti-tumor therapy, no history of other malignant tumors; 3. Stage T1-4N3M0 (UICC / AJCC eighth edition); 4. Patients aged 18-65 years old; 5. No serious heart, lung, liver, kidney and other important organ dysfunction, ECOG score 0-1; 6. White blood cells>=4.0x10^9, neutrophils>=1.5x10^9, platelets>=100x10^9, hemoglobin>=90g/L, transaminase lower than 2 times normal value, creatinine lower than 1.5 times normal value; 7. Signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Receiving anti-tumor treatment, including chemotherapy, radiotherapy, and surgery; 2. Distant metastases before treatment; 3. Known or suspected allergies to research protocol drugs, or perinatal women; 4. Disagree to sign informed consent; 5. Can not cooperate with regular follow-up due to psychological, social, family and geographical reasons; 6. With severe uncontrollable infection or medical disease; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B is defined as HBV-DNA >= 500 IU/ml; hepatitis C is defined as HCV-RNA higher than the detection limit of the analytical method) or co-infection of hepatitis B and C; 8. Organ dysfunction, such as decompensated heart, lung, kidney, liver failure, or can not tolerate radiotherapy and chemotherapy; 9. Patients with factors that affect drug administration, distribution, or metabolism, such as mental abnormalities, central nervous system abnormality, chronic diarrhea, ascites, or pleural effusion; 10. Hypertension, and can not be well controlled by antihypertensive drugs (systolic blood pressure>140mmHg or diastolic blood pressure > 90mmHg); 11. Persistantly using of immunosuppression after organ transplantation drugs; 12. Known history of psychotropic substance abuse or drug use; 13. Patients with history of other malignant tumors before enrollment; 14. Existence of other serious physical or mental diseases or abnormal laboratory tests, which may increase the risk of participating in the study, or interfere with the results of the study, and patients who the investigator believes are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
One-year distant metastasis-free survival;

Secondary

MeasureTime frame
Overall survival;Failure-free survival;Locoregional relapse-free survival;Quality of life;Objective response rate;Safety;

Countries

China

Contacts

Public ContactXiang Yan-Qun

Sun Yat-Sen University Cancer Center

xiangyq@sysucc.org.cn+86 18666096623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026