Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer

NCT04390945 | Unknown Phase 2

• 1 other identifier: FirstHenanUST-EC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

China is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. This study aimed to explore the efficacy and safety of Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival，PFS

  Time from randomization to patient's tumor progression or death

  9 months

Secondary Outcomes (2)

• Overall survival，OS

  1 year

• Objective Response Rate, ORR

  1 year

Study Arms (1)

Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy

EXPERIMENTAL

Camrelizumab (200mg Q2W, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons) Simultaneous radiotherapy (50-50.4Gy / 1.8-2Gy / 25-28F) Chemotherapy (Capecitabine, 625mg/m2, bid, oral, d1-5, qw, total 5 weeks).

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

Camrelizumab combined with concurrent radiotherapy and chemotherapy

Also known as: Capecitabine, concurrent radiotherapy

Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, both men and women;
• Histologically confirmed as esophageal cancer;
• Patients with local recurrence of esophageal cancer after radical treatment;
• ECOG: 0 ～ 1;
• Expected survival time ≥ 12 weeks;
• The function of main organs is normal, that is, it meets the following standards:
• (1) Blood routine examination:
• a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L; (2) Biochemical inspection:
• a. ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; 7. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.

You may not qualify if:

• Does not meet the above selection criteria;
• Patients with distant visceral metastasis;
• Patients with recurrence time \<10 months receiving radical radiotherapy
• Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
• The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included);
• The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose\> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment
• Contraindications to radiotherapy;
• Severe infections that are active or uncontrolled;
• Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method.
• Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study;
• Pregnant or lactating women;
• Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ);
• Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders;
• Patients who have participated in clinical trials of other drugs within four weeks;
• According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 470000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Ruinuo Jia

CONTACT

18537950766; jiaruinuo@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: December 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: August 1, 2024
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

CN (1)