Skip to main content
Clinical Trials/NCT05945901
NCT05945901Active, not recruitingPhase 2

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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country669 target enrollmentStarted: August 14, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
669
Locations
1
Primary Endpoint
Adverse Events (AE) According to NCI-CTCAE v5.0(Phase II)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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.

Arms & Interventions

HR070803

Experimental

HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab

Intervention: HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab (Drug)

HR070803 simulator

Placebo Comparator

HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab

Intervention: HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab (Drug)

Outcomes

Primary Outcomes

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.

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.

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

Secondary Outcomes

  • Disease Control Rate (DCR) by investigator(Phase II)(From Baseline to primary completion date, about 48 months)
  • Serious Adverse Events (SAE)(Phase III)(From Baseline to primary completion date, about 48 months)
  • Overall Response Rate (ORR) Assessed by investigator(Phase II)(From Baseline to primary completion date, about 48 months)
  • Duration of Overall Response (DoR) by investigator(Phase II)(From Baseline to primary completion date, about 48 months)
  • Overall Survival (OS)(Phase II)(From Baseline to primary completion date, about 48 months)
  • Overall Survival (OS)(Phase III)(From Baseline to primary completion date, about 48 months)
  • Progression-Free Survival (PFS) Assessed by investigator(Phase III)(From Baseline to primary completion date, about 48 months)
  • Overall Response Rate (ORR) Assessed by IRC and investigator(Phase III)(From Baseline to primary completion date, about 48 months)
  • Progression-Free Survival (PFS) Assessed by investigator(Phase II)(From Baseline to primary completion date, about 48 months)
  • Characterize the PK(Phase II)(From Baseline to primary completion date, about 48 months)
  • Duration of Overall Response (DoR) by IRC and investigator(Phase III)(From Baseline to primary completion date, about 48 months)
  • Disease Control Rate(DCR) by IRC and investigator(Phase III)(From Baseline to primary completion date, about 48 months)
  • Adverse Events (AE) According to NCI-CTCAE v5.0(Phase III)(From Baseline to primary completion date, about 48 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials