PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Esophageal Cancer Clinical Trial

Official title:

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357846
• Other study ID #: NEOCRTEC2101
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2022
• Est. completion date: January 2031

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: HONG YANG, M.D. Ph.D.
• Phone: 8602087343
• Email: yanghong[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 422
• Est. completion date: January 2031
• Est. primary completion date: January 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.

2. Patients must not have received any prior anticancer therapy.

3. More than 6 months of expected survival.

4. Age ranges from 18 to 70 years.

5. Absolute white blood cells count =4.0×109/L, neutrophil =1.5×109/L, platelets =100.0×109/L, hemoglobin =90g/L, and normal functions of liver and kidney.

6. WHO PS score 0-1

7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients have received any prior anticancer therapy.

2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.

3. Patients with concomitant hemorrhagic disease.

4. Patients who cannot tolerate surgery.

5. Pregnant or breast feeding.

6. Patients without informed consent because of psychological, family, social or any other factors.

7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.

8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.

9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.

10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.

11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.

12. Patients with history of interstitial lung disease or noninfectious pneumonia.

13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.

14. Patients with active hepatitis B ( HBV DNA = 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Oesophageal Cancer
• Squamous Cell Esophageal Carcinoma

Intervention

Drug:
• Sintilimab
Sintilimab 200mg, IV (in the vein) on day 1 and day 22

Radiation:
• Preoperative radiotherapy
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

Drug:
• Paclitaxel
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
• Cisplatin
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

Procedure:
• esophagectomy
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.	At end of enrollment- up to 5 years in follow up
Secondary	Progression free survival	Progression free survival is defined as the time from randomization until objective tumor progression or death.	At end of enrollment- up to 5 years in follow up
Secondary	Pathologic complete response rate	No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes	Two weeks after surgery
Secondary	R0 resection rate	The percentage of patients who undergo complete resection	Two weeks after surgery
Secondary	Incidence of perioperative complications	Incidence of complications	Ninety days after surgery
Secondary	Perioperative mortality	Incidence of death postoperatively	Ninety after surgery