Neoadjuvant Treatment Modalities in Esophageal Cancer

Surgery Clinical Trial

Official title:

Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821843
• Other study ID #: NCC2721
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2002
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xin Wang, MD
• Phone: +861013311583220
• Email: beryl_wx2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chemoradiation
• Chemotherapy Effect
• Esophageal Cancer
• Esophageal Neoplasms
• Esophagogastric Juction Cancer
• Immunotherapy
• Surgery
• Targeted Therapy

Intervention

Drug:
• Platinum based chemotherapy
q1-3W according to physician's preference
• Paclitaxel based chemotherapy
q1-3W according to physician's preference

Radiation:
• Radiotherpay
40-50Gy/1.8-2.2Gy/20-25f

Procedure:
• Surgery
Radical esophagectomy

Drug:
• Immunotherapy
Anti-PD-1/PD-L1 Antibody
• 5-FU Analog based chemotherpay
W1-5 qW or d1-14, q3W according to physician's preference
• Nimotuzumab
200-400mg, d1,qW

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.		1 year, 2 year, 3 year, 5 year
Other	Radiomics analysis	The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.	1 year, 2 year, 3 year, 5 year
Primary	Overall survival		5 year
Secondary	Progression free survival		1 year, 2 year, 3 year, 5 year
Secondary	Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy	Acute and late toxicities are evaluated by NCI-CTC version 5.0	3 months
Secondary	Pathological response rate	Pathological response were classi?ed into three grades.Grade I signi?es 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).	3 months
Secondary	R0 resection rate		3 months
Secondary	Locoregional recurrence free survival		1 year, 2 year, 3 year, 5 year
Secondary	Distant metastasis free survival		1 year, 2 year, 3 year, 5 year