Neoadjuvant chemotherapy combined with perioperative camrelizumab in locally advanced esophageal squamous cell carcinoma

Neoadjuvant chemotherapy combined with camrelizumab followed by camrelizumab monotherapy in locally advanced esophageal squamous cell carcinoma: a prospective, multicenter, randomized controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061094

Enrollment

Unknown

Registered

2022-06-15

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamouse cell carcinoma

Interventions

Treatment group:adjuvant treatment with camrelizumab

control group:none

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, male or female; 2. The pathological diagnosis was thoracic esophageal squamous cell carcinoma; 3. Patients with resectable tumor and without distant metastases; 4. Clinical stage II-IVA (T1b-2N+M0, T3NanyM0) according to imaging and pathological examination; 5. Patients with at least one evaluable lesion according to RECIST V1.1 criteria; 6. ECOG score 0-1 points; 7. Patients whose heart, brain, lung, kidney and other organs function normally and can tolerate surgery; 8. Life expectancy of more than 6 months; 9. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received or are receiving chemotherapy, radiotherapy, immunotherapy or targeted therapy; 2. Patients with distant metastases or unresectable tumor; 3. With other tumors at the same time; 4. Patients with severe impairment of heart, liver and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, and Cr exceeding the upper limit of normal by more than 1.5 times); 5. Patients with a history of autoimmune diseases who are receiving immunosuppressive therapy before enrollment, with an immunosuppressive dose of > 10 mg/day or oral prednisone for more than 2 weeks; 6. Active infection (including hepatitis B virus surface antigen HBVsAg or hepatitis C virus antibody HCV Ab positive); 7. Severe allergies; 8. Abnormal coagulation function: (PT > 16 s, APTT > 53 s, TT > 21 s, Fib < 1.5 g/L), bleeding tendency or in the process of thrombolysis and anticoagulation; 9. Pregnancy or breastfeeding; 10. Other situations that the researchers consider inappropriate for inclusion.

Design outcomes

Primary

Measure	Time frame
three-year overall survival;	—

Secondary

Measure	Time frame
three-year disease-free survival;five-year overall survival;five-year disease-free survival;complete pathological response;major pathological response;safety;	—

Contacts

Public ContactXu Zhang

Sun Yat-sen University Cancer Center

zhangxu@sysucc.org.cn+86 13501546639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026