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

NCT05945901 | Active Not Recruiting Phase 2

• 1 other identifier: HR070803-306-CRC
• Study Type: interventional
• Target: 669
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AE) According to NCI-CTCAE v5.0（Phase II）

  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）

  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）

  from randomization to PD or death from any cause

  From Baseline to primary completion date, about 48 months

Secondary Outcomes (13)

• Overall Response Rate (ORR) Assessed by investigator（Phase II）

  From Baseline to primary completion date, about 48 months

• Disease Control Rate (DCR) 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

• Progression-Free Survival (PFS) Assessed 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

Study Arms (2)

HR070803

EXPERIMENTAL

HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab

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

HR070803 simulator

PLACEBO COMPARATOR

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

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

Interventions

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

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)

HR070803

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

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)

HR070803 simulator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdog, 510060, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: August 14, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

CN (1)