Clinical trial · Interventional
Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors
Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors: Phase II, Multicenter, Randomized, Controlled Clinical Trial
NCT02283489CI-TRIAL-00016007unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin injection | Drug | Cisplatin | ALIAS |
| Paclitaxel injection | Drug | Paclitaxel | ALIAS |
| recombinant human endostatin adenovirus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Combination therapy A
- description
- Recombinant human endostatin adenovirus (EDS01), 5.0 × 1011 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3.
- interventionNames
- Drug: recombinant human endostatin adenovirus
- Drug: Cisplatin injection
- Drug: Paclitaxel injection
- type
- EXPERIMENTAL
- label
- Combination therapy B
- description
- Recombinant human endostatin adenovirus (EDS01), 1.0 × 1012 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3.
- interventionNames
- Drug: recombinant human endostatin adenovirus
- Drug: Cisplatin injection
- Drug: Paclitaxel injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced head and neck cancer unsuitable for surgery or radiotherapy (including head and neck squamous carcinoma and nasopharyngeal carcinoma, which should not more than 30%) * Cytological and/or histopathologic diagnosis * Target lesions can be treated with intratumor injection * Lesions can be measured by imaging with a diameter of ≥2 cm (RECIST1.1) * No chemotherapy, radiotherapy, or biotherapy administered in the past 4 weeks * Age of 18 to 70 years * Life expectation of ≥12 weeks * ECOG performance status of 0 to 2 * Laboratory examinations performed ≤7 days before enrollment with the following results: absolute neutrophil count of ≥1.5 × 109 L-1, platelet count of ≥80 × 109/L, total bilirubin level of ≤2 mg/dL, AST and ALT levels of ≤2 times the upper limit of the reference range, and coagulation parameters ≤1.5 times the upper limit of the reference range * Voluntary participation and written informed consent Exclusion Criteria: * Allergy to EDS01 * Nerves and vessels passing through target lesions do not allow for injection of EDS01 into lesions * Simultaneous radiation of target lesions * Cancer recurrence within 6 months treated by paclitaxel * Severe coagulation dysfunction and bleeding tendency * Serious medical diseases, myocardial infraction in the past 3 months, or acute infection * Currently pregnant or lactating * Any conditions that the investigator regards as unsuitable for the study
References
Publications (0)
Data not yet available
No reference posted for this study.