New treatment for advanced colorectal cancer using HR070803 and standard chemotherapy

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 study is testing a new treatment called HR070803 combined with standard chemotherapy to see if it helps people with advanced colorectal cancer feel better compared to the usual treatment.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 606 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdog)
• Trial ID: NCT05945901 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, randomized, multi-center study involving at least 606 patients with advanced colorectal cancer. It aims to evaluate the safety and efficacy of HR070803 when combined with oxaliplatin, 5-fluorouracil, calcium folinate, and bevacizumab compared to a standard treatment regimen of FOLFOX with bevacizumab. The study will assess how well these combinations work as first-line treatments for patients with unresectable metastatic colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically-confirmed metastatic and unresectable colorectal adenocarcinoma who have not received prior systemic antitumor therapy.

Not a fit: Patients with confirmed MMR deficiency or microsatellite instability high (MSI-H) may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and targeted therapies in treating advanced colorectal cancer.

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.

Where this trial is running

Guangzhou, Guangdog

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdog, China (Recruiting)

Study contacts

• Study coordinator: Yuezheng Ti

Conditions Colorectal Cancer