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Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

Primary Purpose

Colorectal Neoplasms, Intestinal Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Trastuzumab
XELOX regimen
mFOLFOX6 regimen
FOLFIRI regimen
mXELIRI regimen
mIRIS regimen
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up.
  2. Age 18 years or older, male or female.
  3. Have a life expectancy of at least 3 months.
  4. Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer.
  5. HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification.
  6. Patients have not received systemic anti-cancer treatment in the past or had disease progression more than 6 months after receiving after (neo)adjuvant treatment could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
  7. At least one measurable or evaluable lesion, as defined by RECIST 1.1 criteria.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. The functional level of the major organs must meet the following requirements:(1)Blood routine: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90 g/L; (2)Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; Cr≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); for subjects with liver metastasis: TBIL≤3×ULN; ALT and AST≤5×ULN; (3)Patients was not receiving anticoagulation therapy (INR ≤ 1.5 or aPTT ≤ 1.5 × ULN). If the patient received prophylactic anticoagulation therapy and the INR ≤ 2 × ULN within 14 days before the start of the study and the aPTT/PPT is within the normal range could be enrolled; (4)Left ventricular ejection fraction (LVEF) ≥55% (within 28 days).
  10. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

Exclusion Criteria:

  1. Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc.
  2. Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI).
  3. Have any active autoimmune diseases or autoimmune diseases in the past 2 years.
  4. Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment.
  5. Allergic to any monoclonal antibody or chemotherapeutic drug preparation component.
  6. Receive a live attenuated vaccine within 4 weeks before the first dose of study drug treatment.
  7. Known symptomatic central nervous system metastases and/or cancerous meningitis. If subjects with brain metastases who have been treated in the past are in stable condition, they could be enrolled.
  8. Pleural and abdominal effusion requiring clinical treatment, or third interspace effusion.
  9. Suffering from congenital or acquired immune deficiency.
  10. Known history of human immunodeficiency virus (HIV) infection.
  11. Subjects who have received allogeneic tissue/solid organ transplantation.
  12. Known to have active tuberculosis.
  13. Known to have acute or chronic active hepatitis B or acute or chronic active hepatitis C.
  14. Severe infections that are active or poorly clinical controlled.
  15. Known history of (non-infectious) pneumonia requiring steroid treatment or currently suffering from pneumonia.
  16. Other poorly controlled comorbidities.
  17. Pregnancy or breastfeeding or planning to pregnancy or childbirth during the study period.
  18. Have uncontrolled cardiac clinical symptoms or diseases.
  19. Malignant tumors that are progressing or require active treatment in the past 5 years, except for the following: (1) Malignant tumors that have been completely relieved for at least 2 years before enrollment and no other treatment is required during the study period; (2) Non-melanoma skin cancer or malignant freckle-like nevus that has been adequately treated and has no evidence of disease recurrence; (3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence.
  20. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway.

Sites / Locations

  • 270 Dongan Road, Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab combined with trastuzumab and chemotherapy

Arm Description

Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS

Outcomes

Primary Outcome Measures

Objective Response Rate
The proportion of patients with complete response or partial response according to RECIST v1.1

Secondary Outcome Measures

Progression-Free Survival
Time from the initiation of treatment to disease progression or any-cause death
Disease Control Rate
The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1
Overall Survival
Time from the initiation of treatment to any-cause death
Duration of Response
Time from complete response or partial response to disease progression or any-cause death

Full Information

First Posted
December 12, 2021
Last Updated
January 2, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05193292
Brief Title
Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer
Official Title
Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University

4. Oversight

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

5. Study Description

Brief Summary
This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab combined with trastuzumab and chemotherapy
Arm Type
Experimental
Arm Description
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
200mg, iv, 21d for a treatment cycle
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle
Intervention Type
Drug
Intervention Name(s)
XELOX regimen
Intervention Description
Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 regimen
Intervention Description
Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Description
Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w
Intervention Type
Drug
Intervention Name(s)
mXELIRI regimen
Intervention Description
Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w
Intervention Type
Drug
Intervention Name(s)
mIRIS regimen
Intervention Description
Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The proportion of patients with complete response or partial response according to RECIST v1.1
Time Frame
[ Time Frame: Approximately 24 months ]
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Description
Time from the initiation of treatment to disease progression or any-cause death
Time Frame
[ Time Frame: Approximately 24 months ]
Title
Disease Control Rate
Description
The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1
Time Frame
[ Time Frame: Approximately 24 months ]
Title
Overall Survival
Description
Time from the initiation of treatment to any-cause death
Time Frame
[ Time Frame: Approximately 24 months ]
Title
Duration of Response
Description
Time from complete response or partial response to disease progression or any-cause death
Time Frame
[ Time Frame: Approximately 24 months ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up. Age 18 years or older, male or female. Have a life expectancy of at least 3 months. Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer. HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification. Patients have not received systemic anti-cancer treatment in the past or had disease progression more than 6 months after receiving after (neo)adjuvant treatment could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months. At least one measurable or evaluable lesion, as defined by RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The functional level of the major organs must meet the following requirements:(1)Blood routine: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90 g/L; (2)Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; Cr≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); for subjects with liver metastasis: TBIL≤3×ULN; ALT and AST≤5×ULN; (3)Patients was not receiving anticoagulation therapy (INR ≤ 1.5 or aPTT ≤ 1.5 × ULN). If the patient received prophylactic anticoagulation therapy and the INR ≤ 2 × ULN within 14 days before the start of the study and the aPTT/PPT is within the normal range could be enrolled; (4)Left ventricular ejection fraction (LVEF) ≥55% (within 28 days). Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period. Exclusion Criteria: Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc. Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI). Have any active autoimmune diseases or autoimmune diseases in the past 2 years. Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment. Allergic to any monoclonal antibody or chemotherapeutic drug preparation component. Receive a live attenuated vaccine within 4 weeks before the first dose of study drug treatment. Known symptomatic central nervous system metastases and/or cancerous meningitis. If subjects with brain metastases who have been treated in the past are in stable condition, they could be enrolled. Pleural and abdominal effusion requiring clinical treatment, or third interspace effusion. Suffering from congenital or acquired immune deficiency. Known history of human immunodeficiency virus (HIV) infection. Subjects who have received allogeneic tissue/solid organ transplantation. Known to have active tuberculosis. Known to have acute or chronic active hepatitis B or acute or chronic active hepatitis C. Severe infections that are active or poorly clinical controlled. Known history of (non-infectious) pneumonia requiring steroid treatment or currently suffering from pneumonia. Other poorly controlled comorbidities. Pregnancy or breastfeeding or planning to pregnancy or childbirth during the study period. Have uncontrolled cardiac clinical symptoms or diseases. Malignant tumors that are progressing or require active treatment in the past 5 years, except for the following: (1) Malignant tumors that have been completely relieved for at least 2 years before enrollment and no other treatment is required during the study period; (2) Non-melanoma skin cancer or malignant freckle-like nevus that has been adequately treated and has no evidence of disease recurrence; (3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zhang, PHD
Phone
8621-64175590
Email
zhangzhe2010fduscc@gmail.com
Facility Information:
Facility Name
270 Dongan Road, Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

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