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Trial Title:
A Small-sample, Real-world Study of Sintilimab Plus Bevacizumab/Cetuximab Plus XELOX Regimen for Conversion Therapy in Patients With Advanced Colorectal Cancer
NCT ID:
NCT05544812
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab ，bevcizumab/cetuximab，XELOX
Description:
Patients in this group had previously received the following treatment regimens:
Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for
injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W
Arm group label:
experimental
Summary:
The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus
bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced
colorectal cancer
Criteria for eligibility:
Study pop:
Patients with initially unresectable advanced colorectal cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients had to meet all the following conditions to be enrolled in this study:
Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years;
ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as
surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
Baseline blood routine and biochemical parameters of the subjects met the following
criteria:
1. Blood routine examination standards shall meet: A. WBC & GT; 4.0 x 10 / L; b. ANC
> 1.5 x 10 / L; C. the ANC acuity 1.5 x 109 / L; D. HB ≥ 80 g/L; E. PLT acuity
100 x 109 / L;
2. Biochemical tests shall meet the following standards:
A. TBIL 1.5 x ULN or less; B. ALT and AST & LT; 2.5×ULN, ALT and AST & LT for patients
with liver metastases; 5 x ULN; C. BUN and Cr ≤ 1.5 × ULN or endogenous creatinine
clearance ≥ 50 mL/min(Cockcroft-Gault formula).
No history of other tumors； Be willing and able to follow the protocol during the study；
Withdraw from the study at any time during the study without any loss; No history of
other tumors; Be willing and able to follow the protocol during the study; Written
informed consent was provided prior to study screening and was understood by the patient；
Expected life ≥ 6 months
Exclusion Criteria:
- Patients were not admitted to the study if they met any of the following criteria:
1. Cured basal cell carcinoma of the skin and uterus in patients with other
malignancies in the past； Cervical carcinoma in situ is excluded;
2. Patients with known positive HER-2 test;
3. Pregnant or lactating women are in the reproductive period and have not taken
effective contraceptive measures, or have fertility requirements during the study
period;
4. Serious and uncontrolled medical diseases and infections; Chronic bowel disease or
short bowel syndrome;
5. Major organ failure, such as compensatory cardiopulmonary, liver and kidney failure;
Severe abnormal liver and kidney function metabolism, affecting the normal drug
metabolism;
6. Patients with investigator-identified propensity for gastrointestinal bleeding
and/or abnormal coagulation (INR & GT; 1.5);
7. Active HBV or HCV;
8. Patients with peripheral neuropathy NCT-CTCAE ≥ grade 2;
9. Patients who were allergic to the drug in the study protocol were not suitable to
participate in the clinical study.
10. Patients with rheumatic diseases, such as systemic lupus erythematosus, rheumatoid
arthritis, vasculitis, such as ankylosing spondylitis, psoriasis arthritis, gout,
pseudogout, etc. Laboratory tests included positive antinuclear antibody,
anti-DS-DNA antibody, anti-SM antibody, anti-phospholipid antibody, HLA-B27,
rheumatoid factor (RF-igm), anti-cyclic citrulline (CCP) antibody, rheumatoid factor
IgG and IgA, antinuclear factor, anti-keratin antibody, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yang Jianjun
Address:
City:
Xi'an
Zip:
712000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianjun Yang
Phone:
+8613572533693
Start date:
May 1, 2022
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544812
