Envafolimab Combined With Endostatin in Recurrent or Metastatic MSS-type Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Envafolimab
recombinant human endostatin (endostatin)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent form, and had good compliance;
- 18-75 years;
- ECOG 0-1;
- life expectancy of at least 3 months;
- Pathological specimens can be provided for biomarker detection
- Patients with recurrent or metastatic advanced MSS-type colorectal adenocarcinoma diagnosed by pathology and histology, and who are judged by the doctor to be suitable for receiving the nvolimab combined with recombinant human endostatin (endostatin) in this study.
- Previously received second-line standard systemic therapy (chemotherapy cycle at least ≥3 cycles), including fluorouracil or its derivatives, oxaliplatin, irinotecan and bevacizumab treatment, disease progression during or after treatment or Relapse, and have not received immune checkpoint inhibitor therapy before; Note: Patients who have received one regimen of adjuvant or neoadjuvant chemotherapy can be enrolled if they relapse > 6 months after the end of chemotherapy;
- Patients with MSS/pMMR type detected by PCR or IHC in the central laboratory;
- Patients with at least one measurable lesion according to RECIST 1.1, the efficacy evaluation standard for solid tumors, that is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and a single lymph node CT scan has a short diameter ≥15mm;
- Satisfactory main organ function,laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count(ANC) ≥1.5×109/L, platelet count(PLT) ≥80×109/L, Serum creatinine(CR)≤1.5 upper normal limitation (UNL),total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects
Exclusion Criteria:
- Suffered from other malignant tumors within 3 years before the start of treatment in this study;
- The pathological indication is mucinous adenocarcinoma and other special pathological types;
- Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
- Subjects with any severe and/or uncontrolled disease ;
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ;
- Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture;
- Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ;
- Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ;
- Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ;
- Allergic to the active ingredients or excipients of the study drug ;
- Unsuitable for the study or other chemotherapy determined by investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Envafolimab plus recombinant human endostatin (endostatin)
Arm Description
Envafolimab:300mg,sc,d3,Q3W; endostatin:210mg,civ,d1-3,Q3W.
Outcomes
Primary Outcome Measures
ORR
Objective response rate
Secondary Outcome Measures
PFS
Progression Free Survival
OS
Overall Survival
DCR
Disease Control Rate
DOR
Duration of Response
SAE
severity Adverse Event
Full Information
NCT ID
NCT05551247
First Posted
May 31, 2022
Last Updated
September 19, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05551247
Brief Title
Envafolimab Combined With Endostatin in Recurrent or Metastatic MSS-type Colorectal Cancer
Official Title
A Prospective, Single-arm, Multicenter Clinical Trial of Envafolimab Combined With Recombinant Human Endostatin (Endostatin) in the Treatment of Recurrent or Metastatic MSS-type Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
June 28, 2023 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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
The objective is to investigate the efficacy and safety of envafolimab combined with recombinant human endostatin (endostatin) in the treatment of MSS-type colorectal cancer patients with recurrence or metastasis after failure of second-line standard therapy.
Detailed Description
This study is a multicenter, prospective, single-arm clinical study. That is, eligible colorectal cancer patients, after signing the informed consent form, are screened into the group, and will receive continuous intravenous infusion of envafolimab (envafolimab) combined with recombinant human endostatin (endostatin) until the disease. Progressive or intolerable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal 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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Envafolimab plus recombinant human endostatin (endostatin)
Arm Type
Experimental
Arm Description
Envafolimab:300mg,sc,d3,Q3W; endostatin:210mg,civ,d1-3,Q3W.
Intervention Type
Drug
Intervention Name(s)
Envafolimab
Intervention Description
300mg,sc,d3,Q3W;
Intervention Type
Drug
Intervention Name(s)
recombinant human endostatin (endostatin)
Intervention Description
210mg,civ,d1-3,Q3W
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate
Time Frame
From Baseline to disease progress, up to 24 months
Secondary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
From Baseline to primary completion date, about 2 years
Title
OS
Description
Overall Survival
Time Frame
From Baseline to primary completion date, about 2 years
Title
DCR
Description
Disease Control Rate
Time Frame
From Baseline to primary completion date, about 2 years
Title
DOR
Description
Duration of Response
Time Frame
From Baseline to primary completion date, about 2 years
Title
SAE
Description
severity Adverse Event
Time Frame
From Baseline to primary completion date, about 2 years
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:
The subjects voluntarily joined the study, signed the informed consent form, and had good compliance;
18-75 years;
ECOG 0-1;
life expectancy of at least 3 months;
Pathological specimens can be provided for biomarker detection
Patients with recurrent or metastatic advanced MSS-type colorectal adenocarcinoma diagnosed by pathology and histology, and who are judged by the doctor to be suitable for receiving the nvolimab combined with recombinant human endostatin (endostatin) in this study.
Previously received second-line standard systemic therapy (chemotherapy cycle at least ≥3 cycles), including fluorouracil or its derivatives, oxaliplatin, irinotecan and bevacizumab treatment, disease progression during or after treatment or Relapse, and have not received immune checkpoint inhibitor therapy before; Note: Patients who have received one regimen of adjuvant or neoadjuvant chemotherapy can be enrolled if they relapse > 6 months after the end of chemotherapy;
Patients with MSS/pMMR type detected by PCR or IHC in the central laboratory;
Patients with at least one measurable lesion according to RECIST 1.1, the efficacy evaluation standard for solid tumors, that is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and a single lymph node CT scan has a short diameter ≥15mm;
Satisfactory main organ function,laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count(ANC) ≥1.5×109/L, platelet count(PLT) ≥80×109/L, Serum creatinine(CR)≤1.5 upper normal limitation (UNL),total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects
Exclusion Criteria:
Suffered from other malignant tumors within 3 years before the start of treatment in this study;
The pathological indication is mucinous adenocarcinoma and other special pathological types;
Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
Subjects with any severe and/or uncontrolled disease ;
Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ;
Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture;
Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ;
Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ;
Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ;
Allergic to the active ingredients or excipients of the study drug ;
Unsuitable for the study or other chemotherapy determined by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enxiao Li
Phone
0086-13992819833
Email
doclienxiao@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enxiao Li
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Envafolimab Combined With Endostatin in Recurrent or Metastatic MSS-type Colorectal Cancer
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