A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)
Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal mucinous adenocarcinoma (MAC),Camrelizumab,PD-1,anti-angiogenic drugs
Eligibility Criteria
Inclusion Criteria:
- 1. Join the study voluntarily and sign the informed consent;
- 2. Unresectable locally advanced or metastatic colorectal mucinous adenocarcinoma or colorectal adenocarcinoma containing mucinous gland components diagnosed by histopathology or cytology;
- 3. Patients who have received at least first-line and above systemic chemotherapy (which may include platinum, fluorouracil, or irinotecan-based) progress or intolerance (maintenance treatment progress after first-line chemotherapy can also be included). Simultaneous chemoradiotherapy for recurrence or metastasis after surgery is considered as first-line treatment; for radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, It should be counted as a failure of first-line treatment;
- 4. Age 18-75 years old (including boundary value, calculated on the day of signing informed consent), both men and women;
- 5. ECOG score 0-2 points;
- 6. Blood routine and liver and kidney function meet the following conditions: neutrophil count>1.5*10^9/L, hemoglobin concentration>90g/L, platelet count>80*109/L; ALT and AST<2.0*ULN (with liver The transferee may be <5.0*ULN);
- 7. Estimated survival time> 3 months;
- 8. Willing to accept long-term follow-up, willing to provide tumor tissue samples, willing to provide blood samples before and after treatment;
Exclusion Criteria:
- 1. Known predisposition of inherited or acquired bleeding and thrombosis (such as hemophiliacs, coagulopathy, thrombocytopenia, etc.);
- 2. Urinary routines suggest that urine protein ≥ ++ and a confirmed 24-hour urine protein amount> 1.0 g;
- 3. Suffering from active infection, or unexplained fever within 7 days before medication ≥ 38.5℃, or baseline white blood cell count> 15×109/L;
- 4. There are contraindications for immunotherapy (including long-term use of hormones, radiation pneumonia has not been cured and cured within 3 months, etc.);
- 5. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.);
- 6. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc.;
- 7. Active infection requires antimicrobial treatment (for example, antibacterial drugs, antiviral drugs, antifungal drugs);
- 8. Known history of allogeneic organ transplantation and history of transplanted hematopoietic stem cells;
- 9. Patients with interstitial lung disease or previous history of interstitial pneumonia;
- 10. Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders;
- 11. Participated in clinical trials of other anti-tumor drugs within 2 weeks before enrollment;
- 12. Those who have used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
- 13. Previous or concurrently suffering from other uncured malignant tumors, cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer can be included;
- 14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
- 15. According to the investigator's judgment, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, and there are serious laboratory abnormalities , Accompanied by family or social factors, will affect the safety of the subject.
Sites / Locations
- Zhejiang Province Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Two-drug group
Three-drug group
Arm Description
Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Outcomes
Primary Outcome Measures
ORR:Objective Response Rate
Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1
Secondary Outcome Measures
DCR: disease control rate
partial rate of subjects evaluated as CR/PR/SD in all subjects
PFS: progression-free survival
time from randomization to progression and death
OS: overall survival
time from randomization to death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04446091
Brief Title
A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)
Official Title
A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label, single center, non-randomized, phase Ⅱ trial to evaluate safety and efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).
Detailed Description
Colorectal cancer contains multiple pathological types, and one of the more special pathological types is mucinous adenocarcinoma. The prognosis of patients with mucinous adenocarcinoma is not ideal.Some molecular and genetic factors may be related to the characteristics of mucinous adenocarcinoma, in which microsatellite instability and loss of mismatch repair proteins are a focus of current research. Microsatellite instability is often associated with poor differentiation and higher tumor stage. Adenocarcinoma that secretes a large amount of mucus in pathological features.so,In this study, the incidence of ORR and AEs was the main endpoint, and the efficacy and safety of Camrelizumab combined with anti-angiogenic drugs in the treatment of advanced colorectal mucinous adenocarcinoma were observed and evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal mucinous adenocarcinoma (MAC),Camrelizumab,PD-1,anti-angiogenic drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two-drug group
Arm Type
Experimental
Arm Description
Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Arm Title
Three-drug group
Arm Type
Experimental
Arm Description
Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Intervention Type
Drug
Intervention Name(s)
Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)
Intervention Description
Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma
Intervention Type
Drug
Intervention Name(s)
Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan
Intervention Description
Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma
Primary Outcome Measure Information:
Title
ORR:Objective Response Rate
Description
Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
DCR: disease control rate
Description
partial rate of subjects evaluated as CR/PR/SD in all subjects
Time Frame
through study completion, an average of 2 year
Title
PFS: progression-free survival
Description
time from randomization to progression and death
Time Frame
through study completion, an average of 2 year
Title
OS: overall survival
Description
time from randomization to death
Time Frame
through study completion, an average of 2 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:
1. Join the study voluntarily and sign the informed consent;
2. Unresectable locally advanced or metastatic colorectal mucinous adenocarcinoma or colorectal adenocarcinoma containing mucinous gland components diagnosed by histopathology or cytology;
3. Patients who have received at least first-line and above systemic chemotherapy (which may include platinum, fluorouracil, or irinotecan-based) progress or intolerance (maintenance treatment progress after first-line chemotherapy can also be included). Simultaneous chemoradiotherapy for recurrence or metastasis after surgery is considered as first-line treatment; for radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, It should be counted as a failure of first-line treatment;
4. Age 18-75 years old (including boundary value, calculated on the day of signing informed consent), both men and women;
5. ECOG score 0-2 points;
6. Blood routine and liver and kidney function meet the following conditions: neutrophil count>1.5*10^9/L, hemoglobin concentration>90g/L, platelet count>80*109/L; ALT and AST<2.0*ULN (with liver The transferee may be <5.0*ULN);
7. Estimated survival time> 3 months;
8. Willing to accept long-term follow-up, willing to provide tumor tissue samples, willing to provide blood samples before and after treatment;
Exclusion Criteria:
1. Known predisposition of inherited or acquired bleeding and thrombosis (such as hemophiliacs, coagulopathy, thrombocytopenia, etc.);
2. Urinary routines suggest that urine protein ≥ ++ and a confirmed 24-hour urine protein amount> 1.0 g;
3. Suffering from active infection, or unexplained fever within 7 days before medication ≥ 38.5℃, or baseline white blood cell count> 15×109/L;
4. There are contraindications for immunotherapy (including long-term use of hormones, radiation pneumonia has not been cured and cured within 3 months, etc.);
5. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.);
6. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc.;
7. Active infection requires antimicrobial treatment (for example, antibacterial drugs, antiviral drugs, antifungal drugs);
8. Known history of allogeneic organ transplantation and history of transplanted hematopoietic stem cells;
9. Patients with interstitial lung disease or previous history of interstitial pneumonia;
10. Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders;
11. Participated in clinical trials of other anti-tumor drugs within 2 weeks before enrollment;
12. Those who have used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
13. Previous or concurrently suffering from other uncured malignant tumors, cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer can be included;
14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
15. According to the investigator's judgment, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, and there are serious laboratory abnormalities , Accompanied by family or social factors, will affect the safety of the subject.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luo Cong, Doctor of Oncology
Phone
13456711894
Email
lw939291@126.com
Facility Information:
Facility Name
Zhejiang Province Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Cong, Doctor
Phone
13456711894
Email
lw939291@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)
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