RecruitingPhase 2NCT05507411

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC

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）

Sponsor

Zhejiang Cancer Hospital

Enrollment

100 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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；

Exclusion Criteria4

\) Medical condition There is locally advanced unresectable (regardless of stage) or metastatic disease.
Participants with Grade ≥2 Peripheral Neuropathy； Participants with active, known or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic treatment (eg, vitiligo, psoriasis, or alopecia), or disorders that are not expected to recur in the absence of external stimuli are eligible to be enrolled； Participants requiring systemic therapy with glucocorticoids (\>10 mg prednisone equivalent daily) or other immuno suppressive drugs within 14 days prior to treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at \>10 mg prednisone-equivalent daily are permitted； Known history of positive human immuno deficiency virus (HIV) test or known acquired immuno deficiency syndrome (AIDS)； Participants with serious or uncontrolled medical illness； previous/concomitant therapy； Received chest radiotherapy, chemotherapy, immunotherapy, or surgery of the esophagus, esophagus and gastric junction, or stomach prior to the start of the trial.
Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or previous history of interstitial pneumonia； Patients with obvious esophageal ulcers, moderate pain in the chest and back, and esophageal perforation symptoms； Physical examination and laboratory test results
Laboratory screening values must meet the following criteria (using CTCAE 4th edition):