Trial Title:
Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer
NCT ID:
NCT06282445
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
This product is administered by intravenously guttae. The recommended dose of
subcutaneous injection is 1200mg, administered every 3 Weeks (Q3W).
Arm group label:
Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg/m2, ivgtt, d1, Q3W
Arm group label:
Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2, po, bid, d1-14, Q3W Maintenance therapy: 1250mg/m2, po, bid, d1-14, Q3W
Arm group label:
Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
7.5mg/kg，ivgtt, d1, Q3W
Arm group label:
Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
Summary:
To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin +
Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of
Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.
Detailed description:
At present, the survival benefit of MSS mCRC patients is limited, and the general
survival time is only about 3-4 months. Up to now, the standard treatment plan is FOLFOX
combined with bevacizumab. AtezoTRIBE study shows that compared with FOLFOXIRI+
bevacizumab, the standard treatment plan is better than the standard treatment plan. The
combination of PD-L1 monomone attillizumab extended mPFS from 11.4 months to 12.9 months,
showing certain efficacy, and the combination of Attillizumab did not increase adverse
reactions. Based on the above, this study aims to explore the efficacy and safety of
chemotherapy with XELOX (oxaliplatin + capecitabine) regimen and bevacizumab combined
with adbelizumab in first-line treatment of microsatellite stable (MSS) type of initial
unresectable metastatic colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 1.The patients voluntarily participated in the study, signed the informed consent,
and had good compliance.
-
2. Age 18-75 years (including 18 and 75) .
-
3. Metastatic colorectal cancer confirmed histologically and/or cytologically and
initially unresectable.
- 4.MSS or pMMR.
- 5.Patients must have at least one measurable lesion (RECIST 1.1).
- 6.ECOG physical condition 0-1 score.
- 7.Expected survival ≥12 weeks.
- 8.Blood examination (no blood transfusion within 14 days, no correction of
granulocyte colony stimulating factor or other hematopoietic stimulating factor
within 7 days before laboratory examination).
1. neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/L, hemoglobin
concentration ≥9g/dL)
2. Liver function test (bilirubin ≤1.5×ULN; Aspartate aminotransferase and
glutamic acid aminotransferase ≤2.5×ULN, AST and ALT≤5×ULN in the case of liver
metastasis);
3. Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance
(CCr)≥60ml/min);
4. Coagulation, International standardized ratio (INR) ≤1.5×ULN, prothrombin time
(PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
5. Thyroid function, thyroid stimulating hormone (TSH) ≤ the upper limit of normal
(ULN); If there is any abnormality, FT3 and FT4 levels should be examined. If
FT3 and FT4 levels are normal, they can be selected.
- 9.Reproductive-age women must have a negative serum pregnancy test within 14 days
before treatment and be willing to use a medically acceptable effective
contraceptive method (e.g., an intrauterine device, oral contraceptives, or condoms)
during the study and for 3 months after the last study dose; for male subjects who
are married to a reproductive-age woman, surgical sterilization is required or
effective contraception is recommended during the study and for 3 months after the
last study dose.
Exclusion Criteria:
- 1.Received the following treatments within 4 weeks prior to treatment: radiotherapy
for tumors, surgery, chemotherapy, immunotherapy or molecular targeted therapy, or
other investigational medications.
- 2.Active autoimmune disease requiring systemic therapy (i.e., disease-modifying
drugs, corticosteroids, or immunosuppressants) has been used within the past 2
years. Replacement therapies (such as thyroxine, insulin, or physiologic
corticosteroid replacement for adrenal or pituitary insufficiency) are not
considered systemic therapy.
- 3.Diagnosed with an immune deficiency within 7 days prior to the first treatment or
received systemic steroid therapy or any other form of immunosuppressive therapy.
The use of physiological doses of corticosteroids may be approved after consultation
with the sponsor.
- 4.Previously received anti-vascular small-molecule targeted drug therapy, such as
fuquintinib.
- 5.Previous treatment with irinotecan based chemotherapy regimens.
- 6.Symptomatic brain or meningeal metastasis.
- 7.RAS wild-type left half colon cancer.
- 8.Metastatic colorectal cancer with MSI-H or dMMR.
- 9.Severe infection (such as intravenously administered antibiotics, antifungals, or
antivirals) within 4 weeks of treatment, or unexplained fever > 38.5 ° C during
screening/first administration.
- 10.Have high blood pressure that is not well controlled with antihypertensive
medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
mmHg).
- 11.There were obvious clinical bleeding symptoms or obvious bleeding tendency within
3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, black
stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc.
Or treatment of venous/venous thrombosis events within the preceding 6 months, such
as cerebrovascular accidents (including transient ischemic episodes, cerebral
hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet
therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required.
- 12.During screening, it was found that the tumor invaded large vascular structures,
such as pulmonary artery, superior vena cava or inferior vena cava, etc., and the
researchers judged that there was a risk of major bleeding.
- 13.Active heart disease, including myocardial infarction, severe/unstable angina,
occurred 6 months before treatment. Left ventricular ejection fraction <50% by
echocardiography showed poor arrhythmia control.
- 14.Patients have had other malignancies (except cured basal cell carcinoma of the
skin and cervical carcinoma in situ) within the previous 5 years or at the same
time.
- 15.Is known to be allergic to the investigational drug or any of its excipients.
- 16.Active or uncontrolled severe infection.
1. Known human immunodeficiency virus (HIV) infection.
2. Known history of clinically significant liver disease, including viral
hepatitis [active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or
>2000IU/ml) must be excluded for known hepatitis B virus (HBV) carriers.
3. Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies
/mL), or other hepatitis, cirrhosis]
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Jinhua
Zip:
322000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qijia Xuan, MD&Phd
Start date:
March 1, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Agency class:
Other
Source:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282445
