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

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy

Arm Description

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).

Outcomes

Primary Outcome Measures

Progression-free survival,PFS
Time from randomization to patient's tumor progression or death

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2020
Last Updated
January 20, 2022
Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04390945
Brief Title
Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer
Official Title
Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
Capecitabine, concurrent radiotherapy
Intervention Description
Camrelizumab combined with concurrent radiotherapy and chemotherapy
Primary Outcome Measure Information:
Title
Progression-free survival,PFS
Description
Time from randomization to patient's tumor progression or death
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Overall survival,OS
Description
The time from the beginning of randomization to death due to any cause.
Time Frame
1 year
Title
Objective Response Rate, ORR
Description
The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; The investigator considers it unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruinuo Jia
Phone
18537950766
Email
jiaruinuo@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
470000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruinuo Jia, doctor

12. IPD Sharing Statement

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

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