Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2029

Conditions
Larynx CancerHypopharyngeal Cancer
Interventions
PROCEDURE

Surgery

In the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended.

RADIATION

Radiation

"In the surgical group, depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended.~In the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin at a dosage of 30 mg/m²."

DRUG

Toripalimab

In the both groups, starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles.

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
collaborator

Fudan University Eye Ear Nose and Throat Hospital

UNKNOWN

collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

collaborator

Ruijin Hospital

OTHER

collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

lead

Fudan University

OTHER