Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable Esophageal Squamous Cell Carcinoma,A Prospective, Single-Center, Open Label,Phase II Cohort Study (WATCHER)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To observe the 1-year disease-free survival rate (1-year PFS) of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Sign the informed consent. Participants signed and dated written informed consent. Informed consent must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care; Participants must be willing and able to comply with scheduled visits, treatment regimens, and laboratory tests;

• Participant type and target disease characteristics Eastern Collaboration Group (ECOG) physical status score 0-1; Histologically confirmed esophageal cancer with lesions located in the thoracic esophagus, AJCC/UICC esophageal cancer staging (eighth edition) clinical stage cT2-4aNanyM0, or cT1-3N+M0; Presence of measurable lesions according to RECIST criteria; Participants must have tumor tissue samples available for PD-L1 IHC testing; No major associated pathological conditions that increase the risk of surgery to unacceptable levels. Such as: esophageal perforation and active esophageal bleeding, obvious trachea, thoracic large blood vessel invasion; According to the surgeon's assessment, the total lung function can withstand the proposed esophageal cancer resection;

• Age and reproductive status Age ≥18 years old and ≤75 years old; Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent for HCG) within 24 hours prior to initiation of study treatment; Women must be non-nursing;

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
NOT_YET_RECRUITING
Hanzhou
Zhejiang Cancer Hospital
RECRUITING
Hanzhou
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Contact Information
Primary
Qixun Chen
chenqixun64@163.com
+86-13958108371
Backup
Yongling Ji
+86-13958085251
Time Frame
Start Date: 2022-08-03
Estimated Completion Date: 2027-04
Participants
Target number of participants: 100
Treatments
Other: CCR-Watch and Wait
Other: CCR-Surgery
Other: Non-CCR
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov