Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT04393506|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer VEGFR2 Inhibitor Programmed Cell Death 1 Inhibitor Inductive Therapy||Drug: Camrelizumab Drug: Apatinib Procedure: Radical surgery Radiation: Post-operative radiotherapy/chemoradiotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Single-arm Phase I Trial|
|Actual Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2023|
Inductive therapy with Camrelizumab and Apatinib, followed by radical surgery and post-operative radiotherapy/chemoradiotherapy.
Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.
Other Name: Humanized anti-PD-1 inhibitor
Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.
Other Name: VEGFR2 inhibitor
Procedure: Radical surgery
Radical surgery will be performed on the 42th-45th after initiation of inductive therapy
Radiation: Post-operative radiotherapy/chemoradiotherapy
Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.
- Major pathologic response [ Time Frame: One year ]Major pathologic response is based on the pathological examination on the post-operative specimens after inductive therapy.
- 2-year overall survival [ Time Frame: Two years ]The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
- 2-year tumor recurrence rate [ Time Frame: Two years ]The tumor recurrence rate is calculated using the number of patients with tumor recurrence divided by the total number of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393506
|Contact: Ying Liu, Masteremail@example.com|
|Shanghai Ninth People's Hospital||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Ying Liu, Master 23271699 ext 5160 firstname.lastname@example.org|
|Principal Investigator:||Lai-ping Zhong, PHD||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|