Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 66-70Gy will be given in six to seven weeks. Concurrent cisplatin 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Sintilimab 200mg will be given every 3 weeks for 6 cycles, started on day 1 of induction chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune-related adverse events (irAEs) and serious adverse events (irSAEs) | Graded according to CTCAE V5.0 | From the date of informed consent to 100 days after treatment |
| All adverse events (AEs) and serious adverse events (SAEs) | Graded according to CTCAE V5.0 | From the date of informed consent to 100 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who completed radiation within 8 weeks | 8 weeks | |
| The proportion of patients who completed 6 cycles of sintilimab | From the date of informed consent to the end of treatment, assessed up to 20 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | +862087343469 | majun2@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun Ma | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUN YAT-SEN UNIVERSITY cANCER CENTER | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35355438 | Derived | Li XM, Zhang XM, Li JY, Jiang N, Chen L, Tang LL, Mao YP, Li WF, Zhou GQ, Li YQ, Liu N, Zhang Y, Ma J. The immune modulation effects of gemcitabine plus cisplatin induction chemotherapy in nasopharyngeal carcinoma. Cancer Med. 2022 Sep;11(18):3437-3444. doi: 10.1002/cam4.4705. Epub 2022 Mar 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000711728 | spartalizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation. |
|
| Cisplatin | Drug | Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation |
|
|
| intensity-modulated radiotherapy | Radiation | Definitive IMRT of 66-70Gy will be given in six to seven weeks. |
|
|
| Failure-free survival | calculated from the date of informed consent to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first. | 3 years |
| Overall survival | calculated from the date of informed consent to the date of death from any cause. | 3 years |
| Distant failure-free survival | calculated from the date of informed consent to the date of distant metastasis. | 3 years |
| Locoregional failure-free survival | calculated from the date of informed consent to the the date of locoregional persistence or 1st locoregional recurrence. | 3 years |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |