Colorectal AdenocarcinomaNCT05635149
Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Colorectal Cancer
An observational study of Colorectal Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study was an observational cohort study to investigate the efficacy predictors of fuquinitinib combined with anti-PD-1 monoclonal antibody for third-line treatment and above in Chinese patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Sep 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Chinese adults, both male and female, with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. Demographic information (i.e., age and gender) was collected.
Who may be able to join
- Signed the Informed Consent Form
- Ages: 18-75 Years (concluding 18 and 75 Years)
- Pathologically confirmed unresectable metastatic colorectal cancer
- Failure to 2st line therapy
- pMMR/MSS type
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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- Life expectancy greater than 3 months
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan, larger than 20 mm in diameter by conventional CT scan) according to RECIST1.1
- Sufficient organ functions as follows (any blood transfusion or cell growth factor use within 14 days before enrollment is not allowed):
- Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet Count of ≥175×109/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL) ≤1.5 x ULN; ALT and /or AST<1.5 x ULN; If there is liver metastasis, then ALT and/or AST<3.0 x ULN; Serum Creatinine (SCr) ≤1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min；
- Man and woman who childbearing potential agrees to use adequate contraception
- Willingness to provide enough tumor tissues for PD-L1 expression test
Who cannot join
- Patients could not obey the study protocol.
- Previous therapy with VEGFR Inhibitor or anti-PD-1 antibody.
- Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
- Known brain or CNS metastases.
- Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
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- Uncontrolled malignant ascites.
- Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Participation in another clinical trial with any experimental drug within 4 weeks prior to enrollment.
- Clinically significant electrolyte abnormalities judged by researchers.
- Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs.
- Poorly controlled diabetes before enrollment.
- Any factors that influence the usage of oral administration and patients cannot take fruquintinib orally.
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator.
- Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months.
- Active infection or serious infection that is uncontrolled by drug (NCI CTCAE v. 5.0 Grade ≥ 2).
- History of clinically significant hepatic disease, including hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml or >2000IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/ml).
- Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1).
- Pregnant or breastfeeding female patient.
- Receive blood transfusion, blood products and hematopoietic factors such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days prior to enrollment.
- Other severe acute or chronic medical conditions including metabolic disorder, physical examination or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
- Use of immunosuppressive medication, or systemic/local immunosuppressive corticosteroids for complication.
- Patients considered unsuitable for inclusion in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Min Jin
Wuhan, Hubei, 430030
Min Jin, 18807108606, minjin86@126.com
About this study
Official title: Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Metastatic Colorectal Cancer：An Observational Cohort Study
This study was an observational cohort study to investigate the efficacy predictors of fuquinitinib combined with anti-PD-1 monoclonal antibody for third-line treatment and above in Chinese patients with advanced colorectal cancer.
Read the detailed description
Patients with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. All patients will receive a third line therapy with fruquintinib and anti-PD-1 antibody. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Also called drug, Fruquintinib and anti-PD-1
In radiotherapy group, the modality of radiotherapy was conventional radiotherapy (CRT) or stereotactic body radiotherapy (SBRT) for cancer.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib and anti-PD-1 plus radiotherapy | Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off.
anti-PD-1 antibody is administrated as 200mg once every 3 weeks. Patients with isolated or localized metastasis will receive radiotherapy. Receives: Radiation: radiotherapy | |
| Fruquintinib and anti-PD-1 alone | Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease
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 1 year
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
Adverse Event (AEs)
Safety 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 the date of first dose to the 30 days post the last dose
Gut microbiome analysis
To explore the association of gut microbiome and the efficacy of the treatment
Measured: 16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (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 Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635149
- Sponsor's protocol ID
- UNION00168
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Individual data sharing
- No: The datasets will be presented in online repositories: National Center for Biotechnology Information (NCBI), Sequence Read Archive (SRA).
Publications
Cheng M, Jin M, Yang S, Zhao L, Yu D, Lin Z, Li P, Huang C, Liu J, Wang J, Xue J, Ma H, Hu J, Yang K, Zhang T, Liu H. Effect of radiotherapy exposure on fruquintinib plus sintilimab treatment in refractory microsatellite stable metastatic colorectal cancer: a prospective observation study. J Immunother Cancer. 2025 Jan 4;13(1):e009415. doi: 10.1136/jitc-2024-009415.
PubMed 39755582
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Metastatic Colorectal Cancer：An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05635149
- Acronym / sponsor ID
- UNION00168
- Conditions
- Colorectal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Dec 2022 (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 was an observational cohort study to investigate the efficacy predictors of fuquinitinib combined with anti-PD-1 monoclonal antibody for third-line treatment and above in Chinese patients with advanced colorectal cancer.
Detailed description
Patients with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. All patients will receive a third line therapy with fruquintinib and anti-PD-1 antibody. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib and anti-PD-1 plus radiotherapy | – | Radiation: radiotherapyFruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. Patients with isolated or localized metastasis will receive radiotherapy. |
| Fruquintinib and anti-PD-1 alone | – | –Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese adults, both male and female, with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. Demographic information (i.e., age and gender) was collected.
Key inclusion criteria (12 listed)
- Signed the Informed Consent Form
- Ages: 18-75 Years (concluding 18 and 75 Years)
- Pathologically confirmed unresectable metastatic colorectal cancer
- Failure to 2st line therapy
- pMMR/MSS type
Key exclusion criteria (25 listed)
- Patients could not obey the study protocol.
- Previous therapy with VEGFR Inhibitor or anti-PD-1 antibody.
- Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
- Known brain or CNS metastases.
- Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
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 |
|---|---|---|
| radiotherapyAlso: drug, Fruquintinib and anti-PD-1In radiotherapy group, the modality of radiotherapy was conventional radiotherapy (CRT) or stereotactic body radiotherapy (SBRT) for cancer. | Radiation | Fruquintinib and anti-PD-1 plus radiotherapy |
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 1 year
PFS is defined as the time from randomization to the first documented disease
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
Adverse Event (AEs)
Time frame: from the date of first dose to the 30 days post the last dose
Gut microbiome analysis
Time frame: 16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 39755582Cheng M, Jin M, Yang S, Zhao L, Yu D, Lin Z, Li P, Huang C, Liu J, Wang J, Xue J, Ma H, Hu J, Yang K, Zhang T, Liu H. Effect of radiotherapy exposure on fruquintinib plus sintilimab treatment in refractory microsatellite stable metastatic colorectal cancer: a prospective observation study. J Immunother Cancer. 2025 Jan 4;13(1):e009415. doi: 10.1136/jitc-2024-009415.
- Individual participant dataSharing planned: No. The datasets will be presented in online repositories: National Center for Biotechnology Information (NCBI), Sequence Read Archive (SRA).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 12 inclusion and 25 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 2 Dec 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.
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 Hongli Liu, PhD (+86-027-85871962, hongli_liu@hust.edu.cn), or a site near the patient. 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 1 year). 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 NCT05635149, 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 2 Dec 2022.