Colorectal CancerPhase 2/3NCT05945901

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

A Phase 2/3 study testing HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab and HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab in people with Colorectal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colorectal Cancer
What is being tested?: HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab and HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 669 participants
Where: 1 siteChina
Study dates: 14 Aug 2023to 1 Dec 2026
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-Sen University Cancer Center
Guangzhou, Guangdog, 510060

Other trials in China

About this study

Official title: 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.

Conditions: Colorectal Cancer
Being tested: HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab, HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HR070803 plus oxaliplatin, 5-FU/LV, bevacizumabDrug
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 simulator plus oxaliplatin, 5-FU/LV, bevacizumabDrug
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)

Study groups in NCT05945901
Study group	Role	What they receive
HR070803	Experimental	HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab Receives: Drug: HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
HR070803 simulator	Placebo comparator	HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab Receives: Drug: HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: From Baseline to primary completion date, about 48 months

Secondary outcomes (13)

Overall Response Rate (ORR) Assessed by investigator（Phase II）
The proportion of patients who acquired complete response and partial response during treatment.
Measured: From Baseline to primary completion date, about 48 months
Disease Control Rate (DCR) by investigator（Phase II）
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
Measured: From Baseline to primary completion date, about 48 months
Duration of Overall Response (DoR) by investigator（Phase II）
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.
Measured: From Baseline to primary completion date, about 48 months
Progression-Free Survival (PFS) Assessed by investigator（Phase II）
from randomization to PD or death from any cause.
Measured: From Baseline to primary completion date, about 48 months
Overall Survival (OS)（Phase II）
from randomization to death from any cause.
Measured: From Baseline to primary completion date, about 48 months
Characterize the PK（Phase II）
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.
Measured: From Baseline to primary completion date, about 48 months
Overall Survival (OS)（Phase III）
from randomization to death from any cause.
Measured: From Baseline to primary completion date, about 48 months
Progression-Free Survival (PFS) Assessed by investigator（Phase III）
from randomization to PD or death from any cause.
Measured: From Baseline to primary completion date, about 48 months
Overall Response Rate (ORR) Assessed by IRC and investigator（Phase III）
The proportion of patients who acquired complete response and partial response during treatment.
Measured: From Baseline to primary completion date, about 48 months
Duration of Overall Response (DoR) by IRC and investigator（Phase III）
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.
Measured: From Baseline to primary completion date, about 48 months
Disease Control Rate（DCR） by IRC and investigator（Phase III）
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
Measured: From Baseline to primary completion date, about 48 months
Adverse Events (AE) According to NCI-CTCAE v5.0（Phase III）
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.
Measured: From Baseline to primary completion date, about 48 months
Serious Adverse Events (SAE)（Phase III）
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.
Measured: From Baseline to primary completion date, about 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 20231 Dec 2026

First posted14 Jul 2023
Study start14 Aug 2023
Primary completion1 Dec 2025 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 669 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05945901
Sponsor's protocol ID: HR070803-306-CRC
Status last verified: Jul 2025
First submitted: 7 Jul 2023
Last updated: 18 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05945901
Acronym / sponsor ID: HR070803-306-CRC
Conditions: Colorectal Cancer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 669 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 Aug 2023 (actual)
Primary completion: 1 Dec 2025 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 14 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HR070803	Experimental	Drug: HR070803 plus oxaliplatin, 5-FU/LV, bevacizumabHR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
HR070803 simulator	Placebo comparator	Drug: HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumabHR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HR070803 plus oxaliplatin, 5-FU/LV, bevacizumabHR070803 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)	Drug	HR070803
HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumabHR070803 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)	Drug	HR070803 simulator

Primary outcome

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

13 secondary outcomes

Overall Response Rate (ORR) Assessed by investigator（Phase II）
Time frame: 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
Duration of Overall Response (DoR) by investigator（Phase II）
Time frame: 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
Overall Survival (OS)（Phase II）
Time frame: 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
Overall Survival (OS)（Phase III）
Time frame: 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
Overall Response Rate (ORR) Assessed by IRC and investigator（Phase III）
Time frame: 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
Disease Control Rate（DCR） by IRC and investigator（Phase III）
Time frame: 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
Serious Adverse Events (SAE)（Phase III）
Time frame: From Baseline to primary completion date, about 48 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Individual participant dataSharing planned: Undecided

Related trials for Colorectal Cancer

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) According to NCI-CTCAE v5.0（Phase II） (time frame: From Baseline to primary completion date, about 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.