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| ID | Type | Description | Link |
|---|---|---|---|
| 2103232-1 | Other Identifier | IRB of Fudan Univeristy Shanghai Cancer Center |
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The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
Historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy and Toripalimab | Experimental | Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w. Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If ORR of primary tumor is CR/PR, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy TP regimen combined with Toripalimab | Drug | Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w. Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If overall response rate of primary tumor is complete response or partial response, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngeal Preservation rate at 3-month post-radiotherapy | defined as the absence of any residual disease that would justify salvage total laryngectomy | 3-month post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of induction therapy | Overall response rate of induction therapy evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria | 2 weeks after the 3th cycle of induction therapy |
| Overall response rate of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngeal Preservation rate at 3 month post-radiotherapy by different biomarker subgroups | Experimental Biomarker Analysis: the relationship with different biomarkers and 3 month laryngeal preservation rate | 3-month post-radiotherapy |
| Overall response rate of induction therapy, by different biomarker subgroups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiayun He, M.D. | Contact | (86)021-64175590 | 81400 | hexiayun1962@126.com |
| Yu Wang, M.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiayun He, M.D. | Fudan Universtiy Shanghai Cancer Center | Principal Investigator |
| Yu Wang, M.D. | Fudan Universtiy Shanghai Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26681800 | Background | Janoray G, Pointreau Y, Garaud P, Chapet S, Alfonsi M, Sire C, Jadaud E, Calais G. Long-term Results of a Multicenter Randomized Phase III Trial of Induction Chemotherapy With Cisplatin, 5-fluorouracil, +/- Docetaxel for Larynx Preservation. J Natl Cancer Inst. 2015 Dec 16;108(4):djv368. doi: 10.1093/jnci/djv368. Print 2016 Apr. | |
| 2034244 |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
Overall response rate of treatment evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria
| 3 months post-radiotherapy |
| Pathological complete response rate of the patients receiving surgical resection | Pathological complete response rate of the patients receiving surgical resection, evaluated by experienced pathologists | Within 3 weeks after surgery |
| Major pathologic response rate of the patients receiving surgical resection | Major pathologic response rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists. | Within 3 weeks after surgery |
| Overall survival rate at 1 year | Overall survival rate at 1 year | One year post-radiotherapy |
| Overall survival rate at 2 year | Overall survival rate at 2 year | Two year post-radiotherapy |
| Progression-free survival rate at 1 year | Progression-free survival rate at 1 year | One year post-radiotherapy |
| Progression-free survival rate at 2 year | Progression-free survival rate at 2 year | Two year post-radiotherapy |
| Laryngeal Preservation rate at 1 year | Laryngeal Preservation rate at 1 year | One year post-radiotherapy |
| Laryngeal Preservation rate at 2 year | Laryngeal Preservation rate at 2 year | Two year post-radiotherapy |
| Adverse Effect | Adverse Effect, evaluated by CTCAE 4.0.03 | One year post-radiotherapy |
Experimental Biomarker Analysis: the relationship with different biomarkers and overall response rate of induction therapy |
| 2 weeks after the 3th cycle of induction therapy |
| Pathological complete response rate by different biomarker subgroups | Experimental Biomarker Analysis: the relationship with different biomarkers and pathological complete response rate of the patients receiving surgical resection | Within 3 weeks after surgery |
| Major pathologic response rate by different biomarker subgroups | Experimental Biomarker Analysis: the relationship with different biomarkers and major pathologic response rate of the patients receiving surgical resection | Within 3 weeks after surgery |
| Department of Veterans Affairs Laryngeal Cancer Study Group; Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. doi: 10.1056/NEJM199106133242402. |
| 23182993 | Background | Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26. |
| 23341517 | Background | Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. doi: 10.1200/JCO.2012.42.3988. Epub 2013 Jan 22. |
| 30115475 | Background | Weiss J, Gilbert J, Deal AM, Weissler M, Hilliard C, Chera B, Murphy B, Hackman T, Liao JJ, Grilley Olson J, Hayes DN. Induction chemotherapy with carboplatin, nab-paclitaxel and cetuximab for at least N2b nodal status or surgically unresectable squamous cell carcinoma of the head and neck. Oral Oncol. 2018 Sep;84:46-51. doi: 10.1016/j.oraloncology.2018.06.028. Epub 2018 Jul 19. |
| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |