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.
This trial is a prospective, multicenter, randomized controlled phase II clinical study. Eligible patients with thoracic esophageal squamous cell carcinoma in clinical stage cT2-4aNanyM0, or cT1-3N+M0. The patient received radiotherapy (41.4Gy/23F), chemotherapy (nab-paclitaxel combined with carboplatin), immunotherapy (Camrelizumab), and a combination of imaging, endoscopy and biopsy pathology was performed 4-6 weeks after the end of neoadjuvant therapy. Evaluate (CRE1) to determine whether clinical complete resection (cCR) has been achieved. If clinical complete resection is not reached, patients will receive radical surgery; For subjects who have achieved clinical complete resection(cCR), they will be randomly divided into an operation group and an observational waiting group. After 14 weeks, the combined imaging, endoscopy and biopsy pathological evaluation (CRE2) was performed again to determine whether the clinical complete resection (CCR2) was reached. If the patient has local progression and can be resected, radical surgery will be performed; if there is distant progression, medical oncology treatment or supportive treatment will be performed; if clinical complete resection remains, continuous and close imaging, endoscopic and Biopsy pathology combined evaluation (CRE3-14). After achieving clinical complete resection, patients who continue to be followed up for observation or undergo radical surgery, if there is no contraindication to treatment, receive 14 cycles of Camrelizumab maintenance therapy. During follow-up stage, if the patient develops local progression and can be resected, radical surgery is performed; if distant progression occurs, medical oncology treatment or supportive treatment is performed; if clinical complete remission is still achieved, follow-up evaluation can be continued. Among them, the 1-year disease-free survival rate under the esophagus-sparing treatment strategy after achieving clinical complete remission was the main endpoint of the study. To observe the disease-free survival(DFS), overall survival(OS), event-free survival(EFS), quality of life(QoL), failure mode and choice of post-failure treatment mode after neoadjuvant chemoradiotherapy combined with Camrelizumab therapy or after surgical resection. And, the pathological complete remission rate and the main pathological resection rate of the patients who underwent surgery. The blood, stool and tissue samples of patients participating in the trial will be retained for future detection of relevant markers and related laboratory research. Treatment safety and toxicity, including acute and chronic toxicity, will be evaluated on an ongoing basis during treatment and follow-up. Any serious adverse drug reactions will be promptly reported to the hospital ethics committee. The relationship between relevant markers and clinical outcomes will be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
41.4Gy/23F
Paclitaxel for Injection (Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Camrelizumab 200mg Q3W
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hanzhou, Zhejiang, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hanzhou, Zhejiang, China
RECRUITINGNingbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITING1-year DFS of CCR-Watch and Wait group
Time frame: 1 year
Overall Survival
Time frame: 5 years
EFS
Time frame: 5 years
cCR rate
Time frame: 1 year
pCR rate
Time frame: 1 year
MPR rate
Time frame: 1 year
FACT-E
Quality of life
Time frame: 5 years
EORTC QLQ-30
Quality of life
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.