Unresectable Metastatic Colorectal CancerPhase 2NCT04866108
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
A Phase 2 study testing fruquintinib plus capecitabine in people with Unresectable Metastatic Colorectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Metastatic Colorectal Cancer
- What is being tested?
- fruquintinib plus capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2021to Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old at the time of signing the informed consent;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
- Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
- Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
- At least one measurable lesion(s);
- ECOG PS 0-2;
Show all 10Show fewer
- Life expectancy≥3 months;
- Adequate organ and bone marrow functions;
- Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
- Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Previous treatment with VEGFR inhibition;
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Clinically significant electrolyte abnormality;
Show all 19Show fewer
- Clinically significant cardiovascular diseases;
- Thromboembolism or arteriovenous events occurred 6 months before recruited;
- ≥grade 3 bleeding events 4 weeks before recruited;
- Evidence of CNS metastasis;
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
- Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
- History of organ transplantation;
- APTT >1.5×ULN or INR>1.5;
- History of HIV infection or active hepatitis B / C;
- Allergic to fruquintinib and / or capecitabine;
- Pregnant or lactating women;
- Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Patients who are not suitable for the study judged by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.
Read the detailed description
Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.
- Being tested
- fruquintinib plus capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinib plus capecitabineDrug
oral fruquintinib plus capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off Receives: Drug: fruquintinib plus capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: From Baseline to primary completion date, about 3 years
Secondary outcomes (5)
Overall Survival (OS)
OS is determined from the date of treatment to death from any cause or the last follow-up date
Measured: From Baseline to primary completion date, about 3 years
Progression Free Survival (PFS)
PFS is determined from the date of treatment to PD or death from any cause
Measured: From Baseline to primary completion date, about 3 years
Disease Control Rate (DCR)
DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: From Baseline to primary completion date, about 3 years
Adverse Events and Serious Adverse Events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Measured: From Baseline to primary completion date, about 3 years
Quality of Life (QoL)
Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Measured: From Baseline to primary completion date, about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start8 Dec 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Zhigang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866108
- Sponsor's protocol ID
- HMPL-013-FLAG-C104
- Status last verified
- Aug 2022
- First submitted
- 27 Apr 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Bai Z, Deng W, Wang X. Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study. Invest New Drugs. 2025 Apr;43(2):214-222. doi: 10.1007/s10637-025-01510-1. Epub 2025 Feb 13.
PubMed 39945972
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
- ClinicalTrials.gov ID
- NCT04866108
- Acronym / sponsor ID
- HMPL-013-FLAG-C104
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Apr 2021 (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 is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.
Detailed description
Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: fruquintinib plus capecitabineFruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years old at the time of signing the informed consent;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
- Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
- Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
- At least one measurable lesion(s);
Key exclusion criteria (19 listed)
- Previous treatment with VEGFR inhibition;
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
- Proteinuria ≥ 2+ (1.0g/24hr);
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 plus capecitabineoral fruquintinib plus capecitabine | Drug | Experimental |
Primary outcome
Objective Response Rate (ORR)
Time frame: From Baseline to primary completion date, about 3 years
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
5 secondary outcomes
Overall Survival (OS)
Time frame: From Baseline to primary completion date, about 3 years
Progression Free Survival (PFS)
Time frame: From Baseline to primary completion date, about 3 years
Disease Control Rate (DCR)
Time frame: From Baseline to primary completion date, about 3 years
Adverse Events and Serious Adverse Events
Time frame: From Baseline to primary completion date, about 3 years
Quality of Life (QoL)
Time frame: From Baseline to primary completion date, about 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 39945972Wang X, Bai Z, Deng W, Wang X. Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study. Invest New Drugs. 2025 Apr;43(2):214-222. doi: 10.1007/s10637-025-01510-1. Epub 2025 Feb 13.
- Individual participant dataSharing planned: No
Related trials for Unresectable Metastatic Colorectal Cancer
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma
RecruitingPhase 3
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
Colorectal Neoplasms
RecruitingPhase 1
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Colorectal Neoplasms, Gastrointestinal Neoplasms
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.
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 fruquintinib plus capecitabine in people with Unresectable Metastatic Colorectal Cancer, run by Beijing Friendship Hospital 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 10 inclusion and 19 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 18 Aug 2022. 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?
Contact Zhigang Bai (+86-010-63138712, baizhigang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From Baseline to primary completion date, about 3 years). 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 NCT04866108, which also lists 1 linked publication.
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 Aug 2022.