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

Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Camrelizumab

Detailed Description

This is an open clinical study to evaluate the efficacy and safety of Camrelizumab combined with Concurrent Radiotherapy and Chemotherapy in the treatment of locally recurrent esophageal cancer.

Objective to study patients with local recurrence of esophageal cancer after radical treatment.

The study will take progression free survival (PFS) as the main efficacy index, and plan to enroll about 62 patients with local recurrence of esophageal cancer after radical treatment. After fully informed and signed the informed consent, the subjects will enter the experimental stage after screening.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ruinuo Jia; Phone Number: 18537950766; Email: jiaruinuo@163.com

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 470000
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Ruinuo Jia, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-75 years old, both men and women;
2. Histologically confirmed as esophageal cancer;
3. Patients with local recurrence of esophageal cancer after radical treatment;
4. ECOG: 0 ～ 1;
5. Expected survival time ≥ 12 weeks;
6. 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.

Exclusion Criteria:

1. Does not meet the above selection criteria;
2. Patients with distant visceral metastasis;
3. Patients with recurrence time <10 months receiving radical radiotherapy
4. Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
5. 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);
6. 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
7. Contraindications to radiotherapy;
8. Severe infections that are active or uncontrolled;
9. 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.
10. 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;
11. Pregnant or lactating women;
12. Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ);
13. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders;
14. Patients who have participated in clinical trials of other drugs within four weeks;
15. 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;
16. The investigator considers it unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy; 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; Camrelizumab combined with concurrent radiotherapy and chemotherapy; Other Names: Capecitabine; concurrent radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival，PFS	Time from randomization to patient's tumor progression or death	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival，OS	The time from the beginning of randomization to death due to any cause.	1 year
Objective Response Rate, ORR	The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Recurrence; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: FirstHenanUST-EC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No