Clinical trial · Interventional
Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC
Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Complete Response | — | UNRESOLVED | — |
| Induction Therapy | — | UNRESOLVED | — |
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| PD-1 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-cycle induction chemotherapy + immunotherapy | Drug | — | UNRESOLVED |
| Two-cycle induction chemotherapy + immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Two-cycle
- description
- Two cycles induction chemotherapy + immunotherapy
- interventionNames
- Drug: Two-cycle induction chemotherapy + immunotherapy
- type
- ACTIVE_COMPARATOR
- label
- Three-cycle
- description
- Three cycles induction chemotherapy + immunotherapy
- interventionNames
- Drug: Three-cycle induction chemotherapy + immunotherapy
Primary outcomes (1)
- measure
- Complete response
- timeFrame
- At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-65 years old; * Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC/AJCC TNM staging system, 8th edition); * No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.); * At least one measurable lesion on imaging (as per RECIST criteria version 1.1); * ECOG Performance Status (PS): 0-1; * Expected survival ≥3 months; * Male subjects and women of childbearing potential must use contraception from the first dose of study medication until 24 weeks after the last dose of study medication; * Normal major organ function, with basic normal results in hematology, biochemistry, and coagulation tests; * The investigator believes that the treatment will provide a survival benefit. Exclusion Criteria: * Active, known, or suspected autoimmune disease; * Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP \>160 mmHg, diastolic BP \>90 mmHg); * History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours; * Unwell-controlled cardiac clinical symptoms or diseases; * Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction; * Active hepatitis B (HBV DNA ≥2000 IU/mL or 10\^4 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay); * Allergy to any of the study drugs; * Pregnant or breastfeeding women; * Any other factors that, in the investigator's judgment, may cause premature termination of the study.
References
Publications (0)
Data not yet available