Neoadjuvant Treatment Modalities in Esophageal Cancer
- Conditions
- Esophagogastric Juction CancerSurgeryImmunotherapyEsophageal CancerChemotherapy EffectTargeted TherapyChemoradiation
- Interventions
- Radiation: RadiotherpayProcedure: SurgeryDrug: Immunotherapy
- Registration Number
- NCT04821843
- Brief Summary
Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- ≥18 years；
- Esophageal or Esophagogastric cancer；
- Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；
- Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
- ECOG PS score: 0~1；
- Estimated survival time ≥3 months；
- Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；
- Informed consent；
- With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
- Existing active infection such as active tuberculosis and hepatitis；
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；
- Participation in other clinical trials currently or within 4 weeks of selection；
- Pregnant or lactating females；
- Absence of medical records.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Neoadjuvant chemotherapy) nCT Surgery This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT Platinum based chemotherapy This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT Paclitaxel based chemotherapy This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT Radiotherpay This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT Immunotherapy This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT Platinum based chemotherapy This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT Paclitaxel based chemotherapy This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT 5-FU Analog based chemotherpay This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT Surgery This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT Immunotherapy This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT 5-FU Analog based chemotherpay This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant chemotherapy) nCT Nimotuzumab This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. (Neoadjuvant Chemoradiation) nCRT Nimotuzumab This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
- Primary Outcome Measures
Name Time Method Overall survival 5 year
- Secondary Outcome Measures
Name Time Method Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy 3 months Acute and late toxicities are evaluated by NCI-CTC version 5.0
Distant metastasis free survival 1 year, 2 year, 3 year, 5 year Progression free survival 1 year, 2 year, 3 year, 5 year R0 resection rate 3 months Pathological response rate 3 months Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
Locoregional recurrence free survival 1 year, 2 year, 3 year, 5 year
Trial Locations
- Locations (1)
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
🇨🇳Beijing, China