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Nimotuzumab for EGFR-amplified Advanced Pan Solid Tumors

Primary Purpose

Solid Tumor, EGFR Amplification

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Solid Tumor, Nimotuzumab, EGFR

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (left colorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer must be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence or with distant metastasis. Patients with known EGFR amplification and standard treatment depletion or inability to tolerate standard treatment and disease progression. Allow patients with stable symptoms of brain metastasis to be enrolled. Age 18-80 years old, both male and female. Expected life>3 months. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not undergone local treatment such as radiotherapy (lesions located within the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions). It has been confirmed through NGS testing that EGFR amplification exists simultaneously (all cancer species). ECOG: 0-2. Expected survival time ≥ 12 weeks. If the main organs function normally, they meet the following standards: (1) Blood routine examination: a. HB ≥ 90g/L;b. ANC ≥ 1.5 × 10^9/L;c. PLT ≥ 80 × 10^9/L. (2) Biochemical examination: a. ALB ≥ 30g/L;b. ALT and AST ≤ 2.5ULN. If there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min. 8. 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. Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non-lactating patient. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion criteria: The patient has any active autoimmune disease or autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patients with vitiligo. asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included. asthma that requires medical intervention with bronchodilators cannot be included). The patient is currently using systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) and continues to use it within 2 weeks before enrollment. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors. Patients with any severe and/or uncontrollable diseases, including: Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction. Active or uncontrollable serious infections. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10^4 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method). Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies. Pregnant or lactating women. Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ). Patients who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders. Patients who have participated in clinical trials of other drugs within four weeks. Researchers believe that it is not suitable for inclusion.

Sites / Locations

  • Tianjin Medical University Second HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monotherapy or combination therapy based on Nimotuzumab

Arm Description

Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.

Outcomes

Primary Outcome Measures

PFS2/PFS1
The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.

Secondary Outcome Measures

Objective Response Rate(ORR)
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.
Progression-free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
Disease control rate(DCR)
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.
Overall survival(OS)
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
Duration of Response(DOR)
Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Adverse events(AEs)
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.
Quality of Life(QoL)
The Quality of Life scale was used to represent patients' satisfaction with quality of life to evaluate the changes in QOL of patients before and after treatment

Full Information

First Posted
August 19, 2023
Last Updated
August 28, 2023
Sponsor
Tianjin Medical University Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06022276
Brief Title
Nimotuzumab for EGFR-amplified Advanced Pan Solid Tumors
Official Title
An Open ,Single Arm, Prospective and Basket Clinical Study of Nimotuzumab in the Treatment of EGFR-amplified Advanced Pan Solid Tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and Neck Cervical)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital

4. Oversight

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

5. Study Description

Brief Summary
To evaluate the efficacy and safety of nimotuzumab in the treatment of EGFR-amplified advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical).
Detailed Description
Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab for EGFR-amplified advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical) in the real world. The amplification of the patient's EGFR can be determined by tissue-next-generation sequencing (NGS), Liquid-NGS, or fluorescence in situ hybridization (FISH) . EGFR-amplified status identified in any Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. EGFR-amplified status also was assessed for pathogenicity in each case by MTB.Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status. In addition, exploring molecular markers that can predict the efficacy of Nimotuzumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, EGFR Amplification
Keywords
Solid Tumor, Nimotuzumab, EGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy or combination therapy based on Nimotuzumab
Arm Type
Experimental
Arm Description
Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
Primary Outcome Measure Information:
Title
PFS2/PFS1
Description
The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.
Time Frame
Through study completion, an expected average of 1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.
Time Frame
Through study completion, an expected average of 1 year
Title
Progression-free Survival(PFS)
Description
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
Time Frame
The last subject completes at least 24 weeks of follow-up (or disease progression).
Title
Disease control rate(DCR)
Description
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.
Time Frame
Through study completion,an expected average of 1 year
Title
Overall survival(OS)
Description
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
Time Frame
Through study completion, an expected average of 2 years.
Title
Duration of Response(DOR)
Description
Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Time Frame
Through study completion, an expected average of 1 year
Title
Adverse events(AEs)
Description
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.
Time Frame
Through study completion, an expected average of 2 years.
Title
Quality of Life(QoL)
Description
The Quality of Life scale was used to represent patients' satisfaction with quality of life to evaluate the changes in QOL of patients before and after treatment
Time Frame
Through study completion, an expected average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (left colorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer must be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence or with distant metastasis. Patients with known EGFR amplification and standard treatment depletion or inability to tolerate standard treatment and disease progression. Allow patients with stable symptoms of brain metastasis to be enrolled. Age 18-80 years old, both male and female. Expected life>3 months. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not undergone local treatment such as radiotherapy (lesions located within the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions). It has been confirmed through NGS testing that EGFR amplification exists simultaneously (all cancer species). ECOG: 0-2. Expected survival time ≥ 12 weeks. If the main organs function normally, they meet the following standards: (1) Blood routine examination: a. HB ≥ 90g/L;b. ANC ≥ 1.5 × 10^9/L;c. PLT ≥ 80 × 10^9/L. (2) Biochemical examination: a. ALB ≥ 30g/L;b. ALT and AST ≤ 2.5ULN. If there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min. 8. 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. Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non-lactating patient. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion criteria: The patient has any active autoimmune disease or autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patients with vitiligo. asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included. asthma that requires medical intervention with bronchodilators cannot be included). The patient is currently using systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) and continues to use it within 2 weeks before enrollment. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors. Patients with any severe and/or uncontrollable diseases, including: Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction. Active or uncontrollable serious infections. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10^4 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method). Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies. Pregnant or lactating women. Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ). Patients who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders. Patients who have participated in clinical trials of other drugs within four weeks. Researchers believe that it is not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HaiTao Wang, Ph.D
Phone
+86-022-88326385
Email
peterrock2000@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Wang, Ph.D
Phone
+86-022-88326610
Email
wangliliaigang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HaiTao Wang, Ph.D
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Second Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Wang, Ph.D
Phone
+86-022-88326385
Email
peterrock2000@126.com
First Name & Middle Initial & Last Name & Degree
Jinhuan Wang, Ph.D
Phone
+86-18602249531
Email
wjhhappy2008@163.com
First Name & Middle Initial & Last Name & Degree
Haitao Wang
First Name & Middle Initial & Last Name & Degree
Jinhuan Wang
First Name & Middle Initial & Last Name & Degree
Lili Wang
First Name & Middle Initial & Last Name & Degree
Dingkun Hou

12. IPD Sharing Statement

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Nimotuzumab for EGFR-amplified Advanced Pan Solid Tumors

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