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A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab+Radiotherapy

Camrelizumab

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Camrelizumab, IO、Radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

1. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
2. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions;
3. Progress after first-line chemotherapy;
4. There are lesions measurable according to RECIST standards
5. Age ≥18 years old and ≤75 years old, regardless of gender
6. ECOG physical strength status score is 0～2;
7. Have not received immunotherapy or biological therapy before;
8. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L;
9. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min;
10. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
11. No history of interstitial pneumonia or previous interstitial pneumonia;

Exclusion Criteria:

1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
2. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
3. Metastasis of meninges, pleura or pericardium;
4. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
5. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia:
6. Patients who cannot understand the test requirements or may not comply with the test requirements;
7. Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin that does not require systemic treatment Diseases (such as vitiligo, psoriasis);
8. Active hepatitis B or C that requires treatment;
9. Suffered from an active infection requiring systemic treatment 14 days before the first administration;
10. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years;
11. The researcher believes that some obvious diseases should be excluded from this research;
12. The dose limit of radiotherapy cannot meet the limit requirement set by this study.

Sites / Locations

Zhejiang Province Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Combined radiotherapy group

Immunotherapy alone group

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) per RECIST 1.1

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

Overall Survival (OS)

defined as the time from randomization to death from any cause during the course of the study.

Number of Subjects with treatment-related adverse events (AEs)

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Failure mode

Observe and collect the reasons for the treatment failure of the subjects during the study

Full Information

NCT ID

NCT04512417

First Posted

August 11, 2020

Last Updated

August 11, 2020

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04512417

Brief Title

A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer

Official Title

A Multi-Center, Randomized Controlled, Phase II Clinical Study Of Camrelizumab With Or Without Radiotherapy For The Treatment Of Recurrent Or Metastatic Esophageal Cancer That Has Progressed After Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 31, 2020 (Anticipated)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy

Detailed Description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multi-center, randomized controlled, phase II clinical study of camrelizumab with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab with or without radiotherapy for advanced esophageal cancer.

6. Conditions and Keywords

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

Esophageal Cancer

Keywords

Esophageal Cancer, Camrelizumab, IO、Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined radiotherapy group

Arm Type

Experimental

Arm Title

Immunotherapy alone group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Camrelizumab+Radiotherapy

Other Intervention Name(s)

SBRT

Intervention Description

The combined treatment group received radiotherapy for recurring or metastatic lesions: at least one or more lesions were irradiated, stereotactic body radiotherapy (SBRT, 8Gy/time, 3-5 times) or conventional radiotherapy (parts not suitable for SBRT, total Dose 30Gy or more); start immunotherapy within 8 weeks after radiotherapy.Until PD or toxicity is intolerable or up to 24 months.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Intervention Description

Camrelizumab,200mg,Q3W,Until PD or toxicity is intolerable or up to 24 months.

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) per RECIST 1.1

Description

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Description

Time Frame

Up to approximately 6 months.

Title

Overall Survival (OS)

Description

defined as the time from randomization to death from any cause during the course of the study.

Time Frame

Up to 24 months

Title

Number of Subjects with treatment-related adverse events (AEs)

Description

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Time Frame

Up to 24 months

Title

Failure mode

Description

Observe and collect the reasons for the treatment failure of the subjects during the study

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures; 2. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions; 3. Progress after first-line chemotherapy; 4. There are lesions measurable according to RECIST standards 5. Age ≥18 years old and ≤75 years old, regardless of gender 6. ECOG physical strength status score is 0～2; 7. Have not received immunotherapy or biological therapy before; 8. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L; 9. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min; 10. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL; 11. No history of interstitial pneumonia or previous interstitial pneumonia; Exclusion Criteria: 1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug; 2. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed; 3. Metastasis of meninges, pleura or pericardium; 4. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity; 5. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia: 6. Patients who cannot understand the test requirements or may not comply with the test requirements; 7. Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin that does not require systemic treatment Diseases (such as vitiligo, psoriasis); 8. Active hepatitis B or C that requires treatment; 9. Suffered from an active infection requiring systemic treatment 14 days before the first administration; 10. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years; 11. The researcher believes that some obvious diseases should be excluded from this research; 12. The dose limit of radiotherapy cannot meet the limit requirement set by this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Ming, MD

Phone

0571-88122199

chenming@zjcc.org.cn

Facility Information:

Facility Name

Zhejiang Province Cancer Hospital

City

Hanzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen Ming, MD

Phone

0571-88122199

chenming@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer

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