- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282445
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
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: a Prospective, Multicenter, Single-arm Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Dezhi Li, MD&PhD
- Phone Number: 15268685138
- Email: mdlidezhi@163.com
Study Locations
-
-
Zhejiang
-
Jinhua, Zhejiang, China, 322000
- Recruiting
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
-
Contact:
- Qijia Xuan, MD&Phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
- neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥9g/dL)
- 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);
- Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min);
- Coagulation, International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- 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.
- Known human immunodeficiency virus (HIV) infection.
- 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.
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
The enrolled patients with microsatellite stable (MSS) initially unresectable metastatic colorectal cancer will receive a chemotherapy with XELOX and Bevacizumab in combination with Adebrelimab in first-line treatment. XELOX: Oxaliplatin 130 mg/m2, day 1, q3w; Capecitabine 1000 mg/m2, bid, d1-d14, q3w; Bevacizumab: 7.5mg/kg, intravenous infusion, day 1. q3w. Adebrelimab: intravenously guttae, 1200mg, day 1, q3w. 4 cycles. Imaging assessment of tumor remission was performed every 8 weeks. Patients who received 4-6 months of treatment and achieved disease control entered the maintenance treatment stage, receiving maintenance treatment: Bevacizumab: 7.5mg/kg, intravenous infusion, d1, Q3W; Capecitabine: 1250mg/ m2, orally, bid, Q3W; Adebrelimab: 1200mg, intravenous infusion, day 1, Q3W. |
This product is administered by intravenously guttae.
The recommended dose of subcutaneous injection is 1200mg, administered every 3 Weeks (Q3W).
Other Names:
130 mg/m2, ivgtt, d1, Q3W
1000mg/m2, po, bid, d1-14, Q3W Maintenance therapy: 1250mg/m2, po, bid, d1-14, Q3W
7.5mg/kg,ivgtt, d1, Q3W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Up to 2 years
|
Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Organ retention rate
Time Frame: Up to 2 years
|
The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time limit was the sum of complete and partial responses.
|
Up to 2 years
|
Overall survival
Time Frame: Up to 2 years
|
The proportion of participants who remain survival at 2 years
|
Up to 2 years
|
Disease Control Rate
Time Frame: Up to 2 years
|
The percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.
|
Up to 2 years
|
Surgical conversion rate
Time Frame: Up to 2 years
|
The rate of conversion to surgery.
|
Up to 2 years
|
TRAEs
Time Frame: Up to 2 years
|
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
|
Up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dezhi Li, MD&PhD, China, The Fourth Affiliated Hospital Zhejiang University School of Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Capecitabine
- Oxaliplatin
- Bevacizumab
Other Study ID Numbers
- K2024035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer Metastatic
-
Mayo ClinicCompletedMetastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Metastatic... and other conditionsUnited States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Hutchison Medipharma LimitedActive, not recruitingMetastatic Colorectal Cancer | Metastatic Colon CancerUnited States, Spain, Japan, Australia, Austria, Belgium, Czechia, Estonia, France, Germany, Hungary, Italy, Poland, United Kingdom
-
Array Biopharma, now a wholly owned subsidiary...CompletedMetastatic Colorectal Cancer | Advanced Solid Tumors | Advanced or Metastatic Biliary CancerUnited States
-
Zhejiang Cancer HospitalNot yet recruitingMetastatic Colorectal Cancer | Metastatic Colorectal Adenocarcinoma | CRCChina
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Pancreatic Adenocarcinoma | Stage IV Pancreatic Cancer AJCC v6 and v7 | Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Malignant... and other conditionsUnited States
-
AmgenCompletedCancer | Metastatic Colorectal Cancer | Colorectal Cancer | Rectal Cancer | Metastatic Cancer | Colon Cancer
-
Dana-Farber Cancer InstituteAmerican Cancer Society, Inc.Not yet recruitingMetastatic Colorectal Cancer | Colorectal Cancer | Metastatic Colon CancerUnited States
-
AmgenCompletedCancer | Metastatic Colorectal Cancer | Colorectal Cancer | Rectal Cancer | Metastatic Cancer | Colon Cancer | Oncology
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Lung | Resectable Colorectal CarcinomaUnited States
Clinical Trials on Adebrelimab
-
Henan Cancer HospitalNot yet recruiting
-
Fujian Cancer HospitalRecruitingOvarian Diseases | Ovarian NeoplasmsChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
-
Fudan UniversityRecruitingCastration-resistant Prostate Cancer | Prostate Cancer MetastaticChina
-
Zhongzheng XiangNot yet recruitingHead and Neck Squamous Cell Carcinoma
-
Shanghai Hengrui Pharmaceutical Co., Ltd.RecruitingCldn18.2-positive Advanced Solid TumorChina
-
West China HospitalRecruitingEsophageal Squamous Cell CarcinomaChina
-
Sun Yat-sen UniversityWest China Hospital; Nanfang Hospital, Southern Medical UniversityNot yet recruitingNasopharyngeal Carcinoma | Nasopharyngeal CancerChina
-
Hospital of Stomatology, Wuhan UniversityRecruitingClinical IVb Stage Oral Squamous Cell Carcinomas PatientsChina
-
Ningbo Medical Center Lihuili HospitalRecruiting