- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945901
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
August 22, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase II/III, Double-blind, Randomized, Multi-center 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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
606
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuezheng Ti
- Phone Number: +0518-82342973
- Email: yuezheng.ti@hengrui.com
Study Locations
-
-
Guangdog
-
Guangzhou, Guangdog, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Principal Investigator:
- Ruihua Xu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female who is 18-75 years of age;
- Histologically-confirmed metastatic and unresectable (Stage IV as defined by American Joint Committee on Cancer [AJCC eighth edition]) colorectal adenocarcinoma
- 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);
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 ;
- Life expectancy of ≥ 6 months;
- Vital organ functions meet the criteria.
Exclusion Criteria:
- With confirmed MMR deficient (dMMR) or microsatellite instability high (MSI-H).
- With central nervous system metastases.
- Previous oxaliplatin-containing chemotherapy within 12 months prior to enrolment.
- Previous treatment with irinotecan, immune checkpoint inhibitor, anti-epidermal growth factor receptor or any anti-angiogenic drug.
- Patients with large amount of pleural effusion, ascites or pericardial effusion that could not reach a stable state within 2 weeks prior to enrolment.
- Severe gastrointestinal dysfunction (inflammation or diarrhea > grade 1).
- With diagnosed interstitial lung disease.
- Severe cardiovascular and cerebrovascular diseases.
- Peripheral neuropathy > grade 1.
- Intestinal obstruction within the 6 months prior to enrolment.
- Gastrointestinal perforation, gastrointestinal fistula, intraperitoneal abscess, and non-gastrointestinal fistula (e.g. tracheoesophageal fistula) within 6 months prior to enrolment.
- Patients with CTCAE≥ grade 3 gastrointestinal bleeding within 6 months prior to enrolment, or any grade gastrointestinal bleeding within 1 month prior to enrolment.
- 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.
- 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.
- History of hypersensitivity or contraindications to any of irinotecan liposomes/simulator, irinotecan, other liposomal products, 5-FU, calcium folinate, oxaliplatin, bevacizumab.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HR070803
HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
|
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)
|
Placebo Comparator: HR070803 simulator
HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AE) According to NCI-CTCAE v5.0(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment.
An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE.
|
From Baseline to primary completion date, about 48 months
|
Serious Adverse Events (SAE)(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
An SAE is defined as any of the following adverse events in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment: events that result in death, life-threatening events; events requiring hospitalization or prolonged hospitalization; events leading to permanent or severe disability/loss of function (significant impairment of the ability to carry out normal life functions); congenital abnormalities or birth defects; a medically important event or intervention may be required to prevent any of these outcomes.
|
From Baseline to primary completion date, about 48 months
|
Progression-Free Survival (PFS) Assessed by IRC(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
from randomization to PD or death from any cause
|
From Baseline to primary completion date, about 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) Assessed by investigator(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
The proportion of patients who acquired complete response and partial response during treatment.
|
From Baseline to primary completion date, about 48 months
|
Disease Control Rate (DCR) by investigator(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
|
From Baseline to primary completion date, about 48 months
|
Duration of Overall Response (DoR) by investigator(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
For subjects who demonstrated CR or PR, response duration is defined as the time from the date of first response (CR or PR) until the date of first documented disease progression or death.
|
From Baseline to primary completion date, about 48 months
|
Progression-Free Survival (PFS) Assessed by investigator(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
from randomization to PD or death from any cause.
|
From Baseline to primary completion date, about 48 months
|
Overall Survival (OS)(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
from randomization to death from any cause.
|
From Baseline to primary completion date, about 48 months
|
Characterize the PK(Phase II)
Time Frame: From Baseline to primary completion date, about 48 months
|
Serum concentrations of SN-38 and CPT-11 will be monitored.
PK modeling will be performed and an appropriate model will be selected to describe the data.
|
From Baseline to primary completion date, about 48 months
|
Overall Survival (OS)(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
from randomization to death from any cause.
|
From Baseline to primary completion date, about 48 months
|
Progression-Free Survival (PFS) Assessed by investigator(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
from randomization to PD or death from any cause.
|
From Baseline to primary completion date, about 48 months
|
Overall Response Rate (ORR) Assessed by IRC and investigator(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
The proportion of patients who acquired complete response and partial response during treatment.
|
From Baseline to primary completion date, about 48 months
|
Duration of Overall Response (DoR) by IRC and investigator(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
For subjects who demonstrated CR or PR, response duration is defined as the time from the date of first response (CR or PR) until the date of first documented disease progression or death.
|
From Baseline to primary completion date, about 48 months
|
Disease Control Rate(DCR) by IRC and investigator(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
|
From Baseline to primary completion date, about 48 months
|
Adverse Events (AE) According to NCI-CTCAE v5.0(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment.
An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE.
|
From Baseline to primary completion date, about 48 months
|
Serious Adverse Events (SAE)(Phase III)
Time Frame: From Baseline to primary completion date, about 48 months
|
An SAE is defined as any of the following adverse events in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment: events that result in death; life-threatening events; events requiring hospitalization or prolonged hospitalization; events leading to permanent or severe disability/loss of function (significant impairment of the ability to carry out normal life functions); congenital abnormalities or birth defects; a medically important event or intervention may be required to prevent any of these outcomes.
|
From Baseline to primary completion date, about 48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2023
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 7, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
July 1, 2023
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
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Fluorouracil
- Oxaliplatin
- Bevacizumab
Other Study ID Numbers
- HR070803-306-CRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
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
Clinical Trials on HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
-
Martin-Luther-Universität Halle-WittenbergRoche Pharma AGCompletedMetastatic Colorectal CancerGermany
-
Fundación de investigación HMSyntax for Science, S.LCompletedLocally Advanced Rectal Cancer (LARC)Spain
-
NSABP Foundation IncSanofiWithdrawnMetastatic Colorectal Cancer | Colorectal Cancer
-
TakedaActive, not recruiting
-
UMC UtrechtNot yet recruitingMetastatic Colorectal Cancer | Oligometastatic DiseaseNetherlands
-
TakedaCompletedColorectal CancerJapan
-
Uppsala UniversityCompletedGastric Cancer | Peritoneal CarcinomatosisSweden
-
GERCOR - Multidisciplinary Oncology Cooperative...Active, not recruitingQuality of Life | Metastatic Colorectal Cancer | Elderly PatientsFrance