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Trial Title:
A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer
NCT ID:
NCT05945901
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Oxaliplatin
Fluorouracil
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
Description:
HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study drug
after randomization, and those with effective efficacy evaluation (CR, PR or SD) will
receive intravenous chemotherapy for up to 8-12 cycles, and then enter the maintenance
treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent
(whichever occurs first)
Arm group label:
HR070803
Intervention type:
Drug
Intervention name:
HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab
Description:
HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study
drug after randomization, and those with effective efficacy evaluation (CR, PR or SD)
will receive intravenous chemotherapy for up to 8-12 cycles, and then enter the
maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of
informed consent (whichever occurs first)
Arm group label:
HR070803 simulator
Summary:
This is a double-blind, randomized, multi-center, II/III study in at least 606 patients
with advanced colorectal cancer. The study is being conducted to evaluate the safety of
HR070803 combined with oxaliplatin, 5-FU/LV and bevacizumab in phase II and to evaluate
the efficacy of HR070803 in combination with oxaliplatin, 5-FU/LV, and bevacizumab versus
HR070803 simulator in combination with FOLFOX and bevacizumab for first-line treatment of
patients with unresectable metastatic colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female who is 18-75 years of age;
2. Histologically-confirmed metastatic and unresectable (Stage IV as defined by
American Joint Committee on Cancer [AJCC eighth edition]) colorectal adenocarcinoma
3. No previous systemic antitumor therapy (including but not limited to systemic
chemotherapy, molecularly targeted therapy, immunotherapy, biotherapy, and other
investigational therapeutic agents) for colorectal cancer (patients with confirmed
relapse ≥6 months after the last administration of neoadjuvant or adjuvant therapy
can be enrolled);
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 ;
5. Life expectancy of ≥ 6 months;
6. Vital organ functions meet the criteria.
Exclusion Criteria:
1. With confirmed MMR deficient (dMMR) or microsatellite instability high (MSI-H).
2. With central nervous system metastases.
3. Previous oxaliplatin-containing chemotherapy within 12 months prior to enrolment.
4. Previous treatment with irinotecan, immune checkpoint inhibitor, anti-epidermal
growth factor receptor or any anti-angiogenic drug.
5. Patients with large amount of pleural effusion, ascites or pericardial effusion that
could not reach a stable state within 2 weeks prior to enrolment.
6. Severe gastrointestinal dysfunction (inflammation or diarrhea > grade 1).
7. With diagnosed interstitial lung disease.
8. Severe cardiovascular and cerebrovascular diseases.
9. Peripheral neuropathy > grade 1.
10. Intestinal obstruction within the 6 months prior to enrolment.
11. Gastrointestinal perforation, gastrointestinal fistula, intraperitoneal abscess, and
non-gastrointestinal fistula (e.g. tracheoesophageal fistula) within 6 months prior
to enrolment.
12. Patients with CTCAE≥ grade 3 gastrointestinal bleeding within 6 months prior to
enrolment, or any grade gastrointestinal bleeding within 1 month prior to enrolment.
13. Patients with CTCAE≥ grade 3 extra-gastrointestinal bleeding within 6 months prior
to enrolment, or CTCAE≥ grade 2 extra-gastrointestinal bleeding within 3 months
prior to enrolment.
14. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood
pressure ≥90 mmHg under regular antihypertensive therapy), and a history of
hypertensive crisis or hypertensive encephalopathy.
15. History of hypersensitivity or contraindications to any of irinotecan
liposomes/simulator, irinotecan, other liposomal products, 5-FU, calcium folinate,
oxaliplatin, bevacizumab.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Investigator:
Last name:
Ruihua Xu
Email:
Principal Investigator
Start date:
August 14, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945901
