Metastatic Colorectal CancerPhase 2NCT06415851
Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab
A Phase 2 study testing mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody in people with Metastatic Colorectal Cancer and MSS, run by Zhangfa Song at 1 site in China.
Trial summary
Fluorouracil and oxaliplatin-based combined with molecular targeted drugs are still the main treatment strategies for patients with advanced metastatic colorectal cancer (mCRC). Multiple studies have confirmed that anti-PD-1 combined chemotherapy regimens can bring better survival benefits to patients with advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer, MSS
- What is being tested?
- mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- The patient volunteered to participate in the study, signed the informed consent form, and had good compliance.
- Age: 18-75 years old (including 18 years old and 75 years old).
- Body weight of 40kg.
- Metastatic colorectal cancer confirmed by histology and / or cytology and initially unresectable.
- MSS type or pMMR.
- Patients are required to have at least one measurable lesion (RECIST 1.1).
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- ECOG physical strength status: 0-1 point.
- Expected survival of 12 weeks.
- Blood test (no transfusion within 14 days, no correction with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 7 days before the laboratory test)
- Absolute neutrophil value of 1.5109/ L, platelet 1010109/ L, hemoglobin concentration of 9 g/dL);
- Liver function test (bilirubin 1.5 ULN; aspartate aminase and glutamate aminase 2.5 ULN, AST and ALT 5 ULN);
- Renal function (serum creatinine 1.5 ULN or creatinine clearance (CCr) 60 mL/min);
- Coagulation (international normalized ratio (INR) 1.5 ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) 1.5 ULN);
- Thyroid function, upper limit of normal (TSH); if abnormal, FT3 and FT4 levels should be examined, normal FT3 and FT4 levels can be included.
- Women of childbearing age must have a negative serum pregnancy test within 14 days before treatment and be willing to use medically approved effective contraception (e. g., IU, contraceptives or condoms) during 3 months after the study and the last study drug; surgical sterilization for male subjects with a woman of childbearing age, or effective contraception is recommended during the study and 3 months after the last study dose.
Who cannot join
- Have received the following treatments within the first 4 weeks of treatment: tumor radiotherapy, surgery, chemotherapy, immune or molecular targeted therapy, and other clinical study drugs.
- Active autoimmune diseases requiring systemic treatment (i. e., corticosteroids or immunosuppressive agents) have occurred in the past 2 years. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.
- Diagnosis with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first treatment. A physiological dose of corticosteroids may be approved after consultation with the investigator.
- Previous small molecule targeted drug therapy, such as fuquintinib, etc.
- Previous treatment with an oxaliplatin-based chemotherapy regimen.
- Symptomatic brain or meningeal metastases.
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- Metastatic colorectal cancer with either MSI-H or dMMR.
- Severe infection (e. g. intravenous infusion of antibiotics, antifungals or antiviral drugs), or unexplained fever> 38.5℃ during screening / first dose.
- Hypertension that is not well controlled with antihypertensive medication (systolic 140 mmHg or diastolic 90 mmHg).
- Significant clinical bleeding symptoms or significant bleeding tendency (bleeding> 30 mL, hematemesis, black feces, stool within 3 months), hemoptysis (> 5 mL of fresh blood within 4 weeks); or venous / venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; or long-term anticoagulation with Chinese standard or heparin, or long-term antiplatelet therapy (aspirin 300 mg / day or clopidogrel 75 mg / day).
- During screening, the tumor was found to invade large vascular structures, such as pulmonary artery, superior vena cava vein or inferior vena cava vein, which was judged to be at risk of large bleeding by the investigators.
- Active heart disease, including myocardial infarction, severe / unstable angina, within 6 months before treatment. Echocardiography showed a left ventricular ejection fraction of <50%, and the arrhythmia was poorly controlled.
- Other malignancies within or during the previous 5 years (except for cured skin basal cell carcinoma and carcinoma of the cervix in situ).
- Known allergy to the study drug or any of its excipients.
- Active or uncontrolled serious infection; A)known human immunodeficiency virus (HIV) infection; B) known history of clinically significant liver disease, including: viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, namely HBV DNA positive (> 1104 copies / mL or> 2000 IU / mL); known hepatitis C virus infection (HCV) and HCV RNA positive (> 1103 copies / mL)], or other hepatitis, cirrhosis;
- Any other disease, clinically significant metabolic abnormalities abnormal physical examination or laboratory abnormalities, according to the investigator, there is reason to suspect a disease or state is not suitable for the study drug (such as seizures and need treatment), or will affect the interpretation of the results, or make the patient in a high risk situation.
- Routine urine indicates urine protein 2 +, and 24-hour urine protein quantification> 1.0g.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab as First-line Therapy in MSS Unresectable Metastatic Colorectal Cancer: a Prospective, Single-center, Single-arm Trial
Fluorouracil and oxaliplatin-based combined with molecular targeted drugs are still the main treatment strategies for patients with advanced metastatic colorectal cancer (mCRC). Multiple studies have confirmed that anti-PD-1 combined chemotherapy regimens can bring better survival benefits to patients with advanced mCRC. Slulimab is a humanized IgG4 monoclonal antibody with clear anti-tumor efficacy and easy management of adverse reactions. Therefore, the main purpose of this study is to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable mCRC.
Read the detailed description
Colorectal Cancer (CRC) is a common malignant tumor. Its incidence ranks third and second among men and women respectively, and its mortality rate ranks third. Data from the World Health Organization's International Agency for Research on Cancer (IARC) in 2020 show that more than 930,000 patients died due to CRC. Since 2000, the incidence and mortality of colorectal cancer have been steadily increasing in China. The National Cancer Center of China (NCC) reported that there were approximately 408,000 new cases of CRC in China in 2016, and approximately 196,000 deaths. Most of the patients are in the mid-to-late stage when diagnosed, and about 35% of them are in the advanced stage. They have no chance of radical surgery and can only receive palliative care.
In the early days when leucovorin (LV) and 5-fluorouracil (5-FU) were used as the main treatment options for patients with metastatic colorectal cancer (mCRC), the efficacy was poor, and the median overall survival (OS) of patients was only for 8-12 months. Since the introduction of effective cytotoxic drugs such as irinotecan and oxaliplatin in 2000, the combination regimens FOLFOX (5-FU/LV + oxaliplatin) and FOLFIRI (5-FU/LV + irinotecan) have become first-line systemic Standard protocol in treatment. The use of biologics targeting key pathways in the development and progression of mCRC, such as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF)-related pathways, further extends the survival of mCRC patients.
In the latest version of CSCO colorectal cancer diagnosis and treatment guidelines, the main recommended first-line treatments are FOLFOX/FOLFIRI±bevacizumab or cetuximab (both RAS and BRAF are wild-type), FOLFOX/FOLFIRI±bevacizumab (RAS or BRAF mutant).
PD-1 plays an important role in suppressing immune responses and promoting immune tolerance by inhibiting the activity of T cells, allowing cancer cells to evade immune surveillance. Cells in the tumor microenvironment often express PD-1 and PD-L1. Consistent with the inducible expression of PD-L1 by tumor cells, activated CD8+ effector T cells often express PD-1, indicating that tumor cells are resistant to adaptive immune responses. PD-L1 has been found to be expressed in many types of cancer, including melanoma, lung cancer, urothelial cancer, and hepatocellular carcinoma. Its expression can also be induced by various factors such as radiation, which helps cancer cells evade immune regulation. Blocking the PD-1/PD-L1 interaction has been shown to treat a variety of cancers. Clinical studies have proven that anti-PD-1 and anti-PD-L1 monoclonal antibodies can induce long-lasting anti-tumor activity against a variety of tumors. Anti-PD-1 monoclonal antibodies have been approved for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, entities with high microsatellite instability or mismatch repair deficiency and colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma (HCC), Merkel cell carcinoma (MCC), renal cell carcinoma, endometrial cancer, bladder cancer, primary mediastinal large B-cell lymphoma ( PMBCL) and classic Hodgkin lymphoma. A large number of clinical studies of anti-PD-1 antibodies are currently underway, some as monotherapy and some in combination with multiple drugs.
This study is an open-label, single-arm, phase II clinical trial. The study inclusion criteria are patients with unresectable mCRC aged 18-75 years old and histologically confirmed by multidisciplinary treatment (MDT). The patients have RAS gene mutations and are confirmed to be MSS. state. All patients received treatment with sintilimab combined with CapeOx and bevacizumab. After the disease achieved complete response (CR)/partial response (PR)/stable disease (SD), maintenance treatment was performed. The main purpose of the study Endpoints include objective response rate (ORR) as assessed by RECIST v1.1 and adverse events as assessed by CTCAE v5.0. The secondary endpoint is progression-free survival (PFS).
This study mainly aims to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable metastatic colorectal cancer. The second is its safety and tolerability.
- Conditions
- Metastatic Colorectal Cancer, MSS
- Being tested
- mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibodyDrug
This study is a single-arm intervention study. All subjects in this study will be treated with this study protocol, that is, after mFOLFOX6 protocol and bevacizumab induction therapy, combined with slulimumab treatment.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody | Experimental | Induction therapy: mFOLFOX6 regimen + bevacizumab. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 ; LV 400 mg/m2; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; Bevacizumab: 5mg/kg; lasting 2 cycles.
Combination therapy: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 intravenously infused for 90-120 minutes on day 1; LV 400 mg/m2 intravenous infusion for 2 hours, combined with oxaliplatin injection time on day 1; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; bevacizumab: 5mg/kg, intravenously Infusion, day 1, q2w; Slulimab: 200 mg, intravenous infusion, day 1, q2w. Every 2 weeks is a cycle. Receives: Drug: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival(PFS)
The time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (4)
objective response rate(ORR)
It refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time
Measured: through study completion, an average of 1 year
disease control rate(DCR)
Refers to the proportion of patients with best overall assessment of complete response, partial response, or stable disease.
Measured: through study completion, an average of 1 year
overall survival(OS)
Overall survival (os) is defined as the date from randomization to death from any cause.
Measured: 5 years
Adverse events
Vital signs, laboratory indicators, adverse events (AEs) and serious adverse events (SAEs), drug-related AEs and SAEs, and AEs specific to this type of drug (such as hypertension, proteinuria, etc.); according to NCI-CTCAE V5. 0 standard judgment.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangfa Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhangfa Song, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415851
- Sponsor's protocol ID
- SRRS-CAPTUR
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab as First-line Therapy in MSS Unresectable Metastatic Colorectal Cancer: a Prospective, Single-center, Single-arm Trial
- ClinicalTrials.gov ID
- NCT06415851
- Acronym / sponsor ID
- SRRS-CAPTUR
- Conditions
- Metastatic Colorectal Cancer, MSS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhangfa SongUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 16 May 2024 (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.
Fluorouracil and oxaliplatin-based combined with molecular targeted drugs are still the main treatment strategies for patients with advanced metastatic colorectal cancer (mCRC). Multiple studies have confirmed that anti-PD-1 combined chemotherapy regimens can bring better survival benefits to patients with advanced mCRC. Slulimab is a humanized IgG4 monoclonal antibody with clear anti-tumor efficacy and easy management of adverse reactions. Therefore, the main purpose of this study is to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable mCRC.
Detailed description
Colorectal Cancer (CRC) is a common malignant tumor. Its incidence ranks third and second among men and women respectively, and its mortality rate ranks third. Data from the World Health Organization's International Agency for Research on Cancer (IARC) in 2020 show that more than 930,000 patients died due to CRC. Since 2000, the incidence and mortality of colorectal cancer have been steadily increasing in China. The National Cancer Center of China (NCC) reported that there were approximately 408,000 new cases of CRC in China in 2016, and approximately 196,000 deaths. Most of the patients are in the mid-to-late stage when diagnosed, and about 35% of them are in the advanced stage. They have no chance of radical surgery and can only receive palliative care.
In the early days when leucovorin (LV) and 5-fluorouracil (5-FU) were used as the main treatment options for patients with metastatic colorectal cancer (mCRC), the efficacy was poor, and the median overall survival (OS) of patients was only for 8-12 months. Since the introduction of effective cytotoxic drugs such as irinotecan and oxaliplatin in 2000, the combination regimens FOLFOX (5-FU/LV + oxaliplatin) and FOLFIRI (5-FU/LV + irinotecan) have become first-line systemic Standard protocol in treatment. The use of biologics targeting key pathways in the development and progression of mCRC, such as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF)-related pathways, further extends the survival of mCRC patients.
In the latest version of CSCO colorectal cancer diagnosis and treatment guidelines, the main recommended first-line treatments are FOLFOX/FOLFIRI±bevacizumab or cetuximab (both RAS and BRAF are wild-type), FOLFOX/FOLFIRI±bevacizumab (RAS or BRAF mutant).
PD-1 plays an important role in suppressing immune responses and promoting immune tolerance by inhibiting the activity of T cells, allowing cancer cells to evade immune surveillance. Cells in the tumor microenvironment often express PD-1 and PD-L1. Consistent with the inducible expression of PD-L1 by tumor cells, activated CD8+ effector T cells often express PD-1, indicating that tumor cells are resistant to adaptive immune responses. PD-L1 has been found to be expressed in many types of cancer, including melanoma, lung cancer, urothelial cancer, and hepatocellular carcinoma. Its expression can also be induced by various factors such as radiation, which helps cancer cells evade immune regulation. Blocking the PD-1/PD-L1 interaction has been shown to treat a variety of cancers. Clinical studies have proven that anti-PD-1 and anti-PD-L1 monoclonal antibodies can induce long-lasting anti-tumor activity against a variety of tumors. Anti-PD-1 monoclonal antibodies have been approved for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, entities with high microsatellite instability or mismatch repair deficiency and colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma (HCC), Merkel cell carcinoma (MCC), renal cell carcinoma, endometrial cancer, bladder cancer, primary mediastinal large B-cell lymphoma ( PMBCL) and classic Hodgkin lymphoma. A large number of clinical studies of anti-PD-1 antibodies are currently underway, some as monotherapy and some in combination with multiple drugs.
This study is an open-label, single-arm, phase II clinical trial. The study inclusion criteria are patients with unresectable mCRC aged 18-75 years old and histologically confirmed by multidisciplinary treatment (MDT). The patients have RAS gene mutations and are confirmed to be MSS. state. All patients received treatment with sintilimab combined with CapeOx and bevacizumab. After the disease achieved complete response (CR)/partial response (PR)/stable disease (SD), maintenance treatment was performed. The main purpose of the study Endpoints include objective response rate (ORR) as assessed by RECIST v1.1 and adverse events as assessed by CTCAE v5.0. The secondary endpoint is progression-free survival (PFS).
This study mainly aims to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable metastatic colorectal cancer. The second is its safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody | Experimental | Drug: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibodyInduction therapy: mFOLFOX6 regimen + bevacizumab. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 ; LV 400 mg/m2; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; Bevacizumab: 5mg/kg; lasting 2 cycles. Combination therapy: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 intravenously infused for 90-120 minutes on day 1; LV 400 mg/m2 intravenous infusion for 2 hours, combined with oxaliplatin injection time on day 1; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; bevacizumab: 5mg/kg, intravenously Infusion, day 1, q2w; Slulimab: 200 mg, intravenous infusion, day 1, q2w. Every 2 weeks is a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patient volunteered to participate in the study, signed the informed consent form, and had good compliance.
- Age: 18-75 years old (including 18 years old and 75 years old).
- Body weight of 40kg.
- Metastatic colorectal cancer confirmed by histology and / or cytology and initially unresectable.
- MSS type or pMMR.
Key exclusion criteria (17 listed)
- Have received the following treatments within the first 4 weeks of treatment: tumor radiotherapy, surgery, chemotherapy, immune or molecular targeted therapy, and other clinical study drugs.
- Active autoimmune diseases requiring systemic treatment (i. e., corticosteroids or immunosuppressive agents) have occurred in the past 2 years. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.
- Diagnosis with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first treatment. A physiological dose of corticosteroids may be approved after consultation with the investigator.
- Previous small molecule targeted drug therapy, such as fuquintinib, etc.
- Previous treatment with an oxaliplatin-based chemotherapy regimen.
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 |
|---|---|---|
| mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibodyThis study is a single-arm intervention study. All subjects in this study will be treated with this study protocol, that is, after mFOLFOX6 protocol and bevacizumab induction therapy, combined with slulimumab treatment. | Drug | mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody |
Primary outcome
progression free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
4 secondary outcomes
objective response rate(ORR)
Time frame: through study completion, an average of 1 year
disease control rate(DCR)
Time frame: through study completion, an average of 1 year
overall survival(OS)
Time frame: 5 years
Adverse events
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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?
A Phase 2 study testing mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody in people with Metastatic Colorectal Cancer and MSS, run by Zhangfa Song at 1 site in China.
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 15 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
progression free survival(PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.