Colorectal Cancer (CRC)Phase 2ARKNCT07051785
Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer
A Phase 2 study testing Fruquintinib+Irinotecan Liposome+Capecitabine and Bevacizumab+Irinotecan Liposome+Capecitabine in people with Colorectal Cancer (CRC), run by Liu Huang.
Trial summary
This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Fruquintinib+Irinotecan Liposome+Capecitabine and Bevacizumab+Irinotecan Liposome+Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2025to 6 Jul 2028
- Phase
- Phase 2
- 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
- Patients voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
- Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;
- Age: 18-75 (inclusive of 18 and 75), male or female;
- Patients who have previously failed or were intolerant to first-line standard therapy (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure).
- ECOG score: 0-1;
- At least one measurable lesion (based on RECIST 1.1 criteria);
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- Major organs and bone marrow function were essentially normal (no blood components or cell growth factors had been used in the 14 days prior to enrollment):
- Neutrophil count ≥ 1.5 × 10⁹/L;
- Platelet count ≥ 100 × 10⁹/L;
- Hemoglobin ≥ 90 g/L;
- Coagulation parameters: International Normalized Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
- Liver function: Total bilirubin ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (with an exception for patients with liver metastases, where ALT/AST may be up to 5 × ULN);
- Renal function: Serum creatinine ≤ 1.5 × ULN; Creatinine clearance (CCr) ≥ 50 mL/min.
- Female participants of reproductive age must undergo a serum or urinalysis that shows no pregnancy within 14 days before the first dose of study treatment. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and for at least 6 months after the last dose of study medication.
Who cannot join
- History of major surgery or severe trauma within 4 weeks prior to the initiation of the study drug.
- Use of immunosuppressive agents, including systemic or locally absorbed corticosteroids, for immunosuppressive purposes, with a daily dose of prednisone >10 mg or equivalent, and continued us within 2 weeks prior to enrollment.
- Prior exposure to any irinotecan-containing chemotherapy regimen.
- Reception of live attenuated vaccines within 4 weeks prior to the initiation of the study drug.
- Prior treatment with anti-angiogenic small-molecule targeted therapy.
- Presence of any active autoimmune disease or a history of autoimmune disorders (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypopituitarism, vasculitis, nephritis and etc.; not include vitiligo or childhood asthma that has fully resolved and does not require intervention in adulthood; asthma requiring bronchodilator therapy for medical management is included).
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- History of other malignancies within the past 5 years, except for curatively resected skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.
- Congenital or acquired immunodeficiency (e.g., HIV) or active hepatitis (e.g., hepatitis B: HBsAg positive and HBV DNA ≥ 10⁴ copies/mL or >2000 IU/mL; hepatitis C: HCV antibody positive).
- Uncontrolled cardiac clinical symptoms or diseases, including: (1) NYHA classification >2 heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Hypertension that is not well-controlled with antihypertensive medication (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Active or uncontrolled severe infections (≥ CTCAE grade 2 infection).
- Urine routine suggests urinary protein ≥2+ and the amount of urinary protein >1.0g in 24 hours.
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, vomiting blood, black stool, blood in stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke events and/or transient ischemic attack) within 12 months;
- Active peptic ulcer disease, ulcerative colitis, or uncontrolled gastrointestinal bleeding, or any gastrointestinal condition judged by the investigator, which may cause gastrointestinal bleeding, perforation, or bowel obstruction.
- Female participants who are pregnant (positive pregnancy test prior to drug administration) or are breastfeeding;.
- Patients who are allergic to the study drug or excipients.
- Any other conditions judged by the investigator which can potentially affect the study outcomes or compromise the safety or adherence of the participants, such as drug abuse, serious diseases (including psychiatric conditions like epilepsy), or other medical, psychological, or social factors that may endanger participant safety or adherence.
About this study
Official title: Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer：A Multicenter Randomized Controlled Trial
This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. The second phase is designed to further assess the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine compared to bevacizumab in combination with chemotherapy, also as second-line treatment for advanced metastatic colorectal cancer.
The first phase is a single-arm study, while the second phase is a randomized (1:1) controlled trial. Entry into the second phase is determined by the investigators based on the efficacy results from the first phase study: if the primary endpoint of progression-free survival (PFS) is met in the first phase, participants will proceed to the second phase study. In the second phase, randomization is stratified according to the RAS status and the presence of disease progression within six months of adjuvant or neoadjuvant therapy.
In the second phase, patients will be ramdomly assigned to receive fruquintinib(4mg/d, PO, D1-14, Q3W) in combination with irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) and capecitabine(800mg/m2, PO, BID, D1-14, Q3W) or bevacizumab(7.5mg/kg, ivgtt, D1, Q3W) in combination with the same chemotherapy. Every three weeks is a cycle.
Read the detailed description
Colorectal cancer (CRC) is one of the most common malignant tumors in the gastrointestinal tract, ranking third globally in terms of incidence and second in terms of mortality. The incidence rate is higher in developed countries compared to developing countries. According to statistical data from the Chinese Cancer Center in 2018, CRC ranks third and fifth in terms of incidence and mortality, respectively. Due to its insidious onset and non-specific clinical manifestations, the early detection rate of CRC is relatively low. Approximately 50% to 60% of patients diagnosed at an advanced stage, often with metastasis.
The treatment of colorectal cancer (CRC) encompasses surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy. For patients with early-stage CRC, curative surgery is the primary therapeutic approach; however, recurrence and metastasis remain potential risks. In contrast, for patients with metastatic, unresectable CRC (mCRC), the treatment aims to prolong survival and improve quality of life . According to the guidelines, systemic therapy primarily involves chemotherapy and, in some cases, the combination of chemotherapy and targeted agents . Traditional chemotherapeutic agents include 5-FU, capecitabine, irinotecan, oxaliplatin, and etc.. Commonly used targeted therapies include monoclonal antibodies, such as bevacizumab and cetuximab. The use of these biologics which are blocking key pathways in the progression of mCRC has further prolonged patient survival. However, most patients with unresectable metastatic CRC experience disease progression or develop unacceptable toxicity during first-line systemic therapy, necessitating the initiation of second-line treatment.
The goal of this clinical trial is to evaluate the efficacy and safety of fruquintinib combined with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer in patients histopathologically confirmed unresectable colorectal cancer, who have previously failed or were intolerant to standard treatment.
This study is a multicenter, two-stage, randomized controlled trial. Participants were enrolled from patients who had previously received standard first-line therapy based on oxaliplatin, which failed or was not tolerated. The study aims to further evaluate the efficacy and safety of the combination of fruquintinib, irinotecan liposome, and capecitabine compared to bevacizumab combined with chemotherapy as second-line treatment for metastatic, unresectable colorectal cancer (mCRC).
Study Design:
Stage 1: Single-Arm Cohort
- A total of 28 patients were enrolled in this phase.
- Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles.
- If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine.
- Imaging assessments were conducted every 6 weeks (±7 days), and responses were evaluated according to RECIST 1.1 criteria.
Stage 2: Randomized (1:1) Controlled Trial
- Based on the results of the first stage, investigators determined whether to proceed to the second stage. If the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage.
- A total of 40 patients were planned to be enrolled in this phase.
- Randomization was stratified based on RAS mutation status and disease progression within 6 months of adjuvant or neoadjuvant therapy.
- Participants were randomly assigned to two groups (A and B), each consisting of 20 patients:
- Group A: Fruquintinib + irinotecan liposome + capecitabine
- Group B: Bevacizumab + irinotecan liposome + capecitabine
- After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy:
- Group A: Fruquintinib + capecitabine
- Group B: Bevacizumab + capecitabine
- Imaging assessments were conducted every 6 weeks (±7 days), and responses were evaluated according to RECIST 1.1 criteria
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Fruquintinib+Irinotecan Liposome+Capecitabine, Bevacizumab+Irinotecan Liposome+Capecitabine
- Keywords
- Colorectal Cancer, Fruquintinib, Second-Line
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib+Irinotecan Liposome+CapecitabineDrug
Stage 1: Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles. If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine.
Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group A: Fruquintinib + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with Fruquintinib + capecitabine
Bevacizumab+Irinotecan Liposome+CapecitabineDrug
Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group B: Bevacizumab + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with bevacizumab + capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib+Irinotecan Liposome+Capecitabine | Experimental | fruquintinib(4mg/d, PO, D1-14, Q3W) + irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three weeks is a cycle. Receives: Drug: Fruquintinib+Irinotecan Liposome+Capecitabine |
| Bevacizumab+Irinotecan Liposome+Capecitabine | Active comparator | bevacizumab(7.5mg/kg, ivgtt, D1, Q3W)+irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three weeks is a cycle. Receives: Drug: Bevacizumab+Irinotecan Liposome+Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: one year
Secondary outcomes (3)
Objective Response Rate (ORR)
the proportion of patients with complete response or partial response, using RECIST v 1.1.
Measured: one year
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Measured: one year
Overall survival (OS)
time from randomization to death from any cause
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start7 Jul 2025 (estimated)
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Huang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051785
- Sponsor's protocol ID
- HMPL-013-FLAG-C135
- Acronym
- ARK
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer：A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07051785
- Acronym / sponsor ID
- ARK / HMPL-013-FLAG-C135
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Colorectal Cancer, Fruquintinib, Second-Line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Liu HuangUniversity, hospital or other
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2028 (estimated)
- First posted
- 4 Jul 2025 (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.
This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. The second phase is designed to further assess the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine compared to bevacizumab in combination with chemotherapy, also as second-line treatment for advanced metastatic colorectal cancer.
The first phase is a single-arm study, while the second phase is a randomized (1:1) controlled trial. Entry into the second phase is determined by the investigators based on the efficacy results from the first phase study: if the primary endpoint of progression-free survival (PFS) is met in the first phase, participants will proceed to the second phase study. In the second phase, randomization is stratified according to the RAS status and the presence of disease progression within six months of adjuvant or neoadjuvant therapy.
In the second phase, patients will be ramdomly assigned to receive fruquintinib(4mg/d, PO, D1-14, Q3W) in combination with irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) and capecitabine(800mg/m2, PO, BID, D1-14, Q3W) or bevacizumab(7.5mg/kg, ivgtt, D1, Q3W) in combination with the same chemotherapy. Every three weeks is a cycle.
Detailed description
Colorectal cancer (CRC) is one of the most common malignant tumors in the gastrointestinal tract, ranking third globally in terms of incidence and second in terms of mortality. The incidence rate is higher in developed countries compared to developing countries. According to statistical data from the Chinese Cancer Center in 2018, CRC ranks third and fifth in terms of incidence and mortality, respectively. Due to its insidious onset and non-specific clinical manifestations, the early detection rate of CRC is relatively low. Approximately 50% to 60% of patients diagnosed at an advanced stage, often with metastasis.
The treatment of colorectal cancer (CRC) encompasses surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy. For patients with early-stage CRC, curative surgery is the primary therapeutic approach; however, recurrence and metastasis remain potential risks. In contrast, for patients with metastatic, unresectable CRC (mCRC), the treatment aims to prolong survival and improve quality of life . According to the guidelines, systemic therapy primarily involves chemotherapy and, in some cases, the combination of chemotherapy and targeted agents . Traditional chemotherapeutic agents include 5-FU, capecitabine, irinotecan, oxaliplatin, and etc.. Commonly used targeted therapies include monoclonal antibodies, such as bevacizumab and cetuximab. The use of these biologics which are blocking key pathways in the progression of mCRC has further prolonged patient survival. However, most patients with unresectable metastatic CRC experience disease progression or develop unacceptable toxicity during first-line systemic therapy, necessitating the initiation of second-line treatment.
The goal of this clinical trial is to evaluate the efficacy and safety of fruquintinib combined with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer in patients histopathologically confirmed unresectable colorectal cancer, who have previously failed or were intolerant to standard treatment.
This study is a multicenter, two-stage, randomized controlled trial. Participants were enrolled from patients who had previously received standard first-line therapy based on oxaliplatin, which failed or was not tolerated. The study aims to further evaluate the efficacy and safety of the combination of fruquintinib, irinotecan liposome, and capecitabine compared to bevacizumab combined with chemotherapy as second-line treatment for metastatic, unresectable colorectal cancer (mCRC).
Study Design:
Stage 1: Single-Arm Cohort
- A total of 28 patients were enrolled in this phase.
- Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles.
- If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine.
- Imaging assessments were conducted every 6 weeks (±7 days), and responses were evaluated according to RECIST 1.1 criteria.
Stage 2: Randomized (1:1) Controlled Trial
- Based on the results of the first stage, investigators determined whether to proceed to the second stage. If the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage.
- A total of 40 patients were planned to be enrolled in this phase.
- Randomization was stratified based on RAS mutation status and disease progression within 6 months of adjuvant or neoadjuvant therapy.
- Participants were randomly assigned to two groups (A and B), each consisting of 20 patients:
- Group A: Fruquintinib + irinotecan liposome + capecitabine
- Group B: Bevacizumab + irinotecan liposome + capecitabine
- After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy:
- Group A: Fruquintinib + capecitabine
- Group B: Bevacizumab + capecitabine
- Imaging assessments were conducted every 6 weeks (±7 days), and responses were evaluated according to RECIST 1.1 criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib+Irinotecan Liposome+Capecitabine | Experimental | Drug: Fruquintinib+Irinotecan Liposome+Capecitabinefruquintinib(4mg/d, PO, D1-14, Q3W) + irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three weeks is a cycle. |
| Bevacizumab+Irinotecan Liposome+Capecitabine | Active comparator | Drug: Bevacizumab+Irinotecan Liposome+Capecitabinebevacizumab(7.5mg/kg, ivgtt, D1, Q3W)+irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three 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 (14 listed)
- Patients voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
- Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;
- Age: 18-75 (inclusive of 18 and 75), male or female;
- Patients who have previously failed or were intolerant to first-line standard therapy (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure).
- ECOG score: 0-1;
Key exclusion criteria (17 listed)
- History of major surgery or severe trauma within 4 weeks prior to the initiation of the study drug.
- Use of immunosuppressive agents, including systemic or locally absorbed corticosteroids, for immunosuppressive purposes, with a daily dose of prednisone >10 mg or equivalent, and continued us within 2 weeks prior to enrollment.
- Prior exposure to any irinotecan-containing chemotherapy regimen.
- Reception of live attenuated vaccines within 4 weeks prior to the initiation of the study drug.
- Prior treatment with anti-angiogenic small-molecule targeted therapy.
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 |
|---|---|---|
| Fruquintinib+Irinotecan Liposome+CapecitabineStage 1: Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles. If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine. Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group A: Fruquintinib + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with Fruquintinib + capecitabine | Drug | Fruquintinib+Irinotecan Liposome+Capecitabine |
| Bevacizumab+Irinotecan Liposome+CapecitabineStage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group B: Bevacizumab + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with bevacizumab + capecitabine | Drug | Bevacizumab+Irinotecan Liposome+Capecitabine |
Primary outcome
Progression-free Survival (PFS)
Time frame: one year
time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
Overall survival (OS)
Time frame: two years
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 4 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib+Irinotecan Liposome+Capecitabine and Bevacizumab+Irinotecan Liposome+Capecitabine in people with Colorectal Cancer (CRC), run by Liu Huang.
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 14 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: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Progression-free Survival (PFS) (time frame: one year). 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 4 Jul 2025.