Colorectal CancerPhase 2NCT04695470
Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients
A Phase 2 study testing Fruquintinib and Sintilimab in people with Colorectal Cancer, run by Aiping Zhou at 1 site in China.
Trial summary
This is a prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fruquintinib and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Jun 2022
- 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
- Fully understand the study and signed the Informed Consent Form (ICF) out of their own will;
- Histologically or cytologically diagnosed with metastasis colorectal adenocarcinoma CRC (Phase IV)
- MSS or MSI-low, MSI was assessed per local guidelines (immunohistochemistry and/or polymerase chain reaction [PCR]) prior to screening. Tumor samples with instability in 0 or 1 marker were identified as microsatellite-stable and MSI-low, respectively.
- TMB≥5 mutations/Mb, TMB was performed on plasma samples by NGS.
- Subjects who failed at least second line standard chemotherapies including Fluorouracil, Oxaliplatin, Irinotecan and VEGF inhibitors(e.g., bevacizumab). Pre-treatment with anti-EGFR(e.g., cetuximab) were mandatory if RAS wild and left side. Failed therapies are defined as the occurance of PD or intolerable toxicities during the treatment or within 3 months after the last dose.
- Subject must not receive any systematically anti-tumor therapies during the last 4 weeks, and never receive any vascular endothelial growth factor (VEGFR) inhibitor or Immune checkpoint blockade.
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- 18-75 years of age (inclusive)
- Body weight≥40Kg
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Patients capable of taking oral medication
- Patients with evaluable or measurable lesions as per RECIST version 1.1
- Expected survival >12 weeks
Who cannot join
- with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
- Previous treatment with Fruquintinib or immune checkpoint inhibitors
- Absolute neutrophil count (ANC)<1.5×109/L, or blood platelet count (PLT)<100×109/L, or hemoglobin<90g/L; blood transfusion within 1 week before enrollment for the purpose of enrollment is not allowed;
- Serum total bilirubin>1.5×Upper Limit of Normal (ULN);Alanine transaminase(ALT) and/or Aspartate transferase (AST)>2.5×ULN (subject to the normal value at each site); or ALT and/or AST > 5×ULN for patients with liver metastases;
- Creatinineclearancerate< 50mL/min;
- Uncontrolled hypertension by monotherapy, i.e. systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after monotherapy treatment.
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- Clinical significant electrolyte abnormality;
- Results of urine protein detection with 2+ or above, or urinary protein quantity ≥1.0g/24h;
- Unrecovered toxicity fromprevious anticancer therapies(NCI CTC AE>Grade 1, except for alopecia and ≤Grade 2 neurotoxicity caused by Oxaliplatin), not fully recovered from previous surgeries; or the time from the last anticancer therapy or surgery is less than 4 weeks;
- Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
- Subjects with presence of clinically detectable second primary malignant tumors at enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix).
- Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C(previous medical history of hepatitis B virus infection regardless of drug control, HBV DNA≥104×copynumberor ≥2000IU/mL);
- Difficulty in swallowing or known drug malabsorption;
- Duodenal ulcer, ulcerative colitis, intestinal obstruction, other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigator's judgment; or with a history of intestinal perforation or intestinal fistula, which were not fully recovered after surgery;
- History of artery thrombosis or deep venous thrombosis within 6 months before enrollment, or have evidence or a history of bleeding tendency within 2 months before the enrollment, regardless of severity;
- Occurrence of stroke or transient ischemic attack within 12 months before the enrollment;
- Activated Partial Thromboplastin Time (APTT) and/or prothrombin time (PT) > 1.5×ULN (subject to the normal range at each site);
- Skin wounds, surgical site, trauma site, severe mucosal ulcers or fracture not completely healed;
- Acute myocardial infarction, severe/unstable angina or received coronary artery bypass surgery within 6 months prior to enrollment; or patients with cardiac insufficiency of NYHA Grade 2 or above;
- Pregnant or lactating women Or female subjects with childbearing potentials with positive pregnancy test result before the first time of study drug treatment;
- Any clinical or laboratory abnormalities or compliance concerns unfit to participate in this clinical trial according to the investigator's judgment;
- Serious psychological or psychiatric disorders;
- Contraindications of immune checkpoint inhibitors
- Participated in any other drug clinical trial during the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Aiping Zhou, 8610-87788145, zhouap1825@126.com
About this study
Official title: Phase II Trial of Fruquintinib With Sintilimab in Treating Refractory Metastatic Colorectal Cancer Patients With TMB(Tumor Mutation Burden)-High and Non-MSI(Microsatellite Instability)-High
This is a prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.
Patients had to have received at least a second-line standard therapy, including fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial growth factor) inhibitors and to have disease progression within 3 months after the last administration of the last standard therapy or to have stopped such therapy due to unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were mandatory if RAS(Rat sarcoma virus) wild and left side .
Patients who met the eligibility criteria took fruquintinib plus Sintilimab until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival) rate at 6 months.
- Conditions
- Colorectal Cancer
- Being tested
- Fruquintinib and Sintilimab
- 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 and SintilimabDrug
fruquintinib 5mg qd for 2 weeks on and 1 week off, Q3w
Sintilimab 200mg iv, Q3w
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib with Sintilimab | Experimental | Patients who met the eligibility criteria took fruquintinib 5mg qd for 2 weeks on and 1 week off Q3w plus Sintilimab 200mg iv, Q3w. Receives: Drug: Fruquintinib and Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS(progression free survival) rate at 6 months
To determine the clinical effectiveness of the study treatment assessed using PFS rate at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiping Zhou
- Responsible party
- Sponsor-investigator, Aiping Zhou, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695470
- Sponsor's protocol ID
- NCC2091
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- 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 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Fruquintinib With Sintilimab in Treating Refractory Metastatic Colorectal Cancer Patients With TMB(Tumor Mutation Burden)-High and Non-MSI(Microsatellite Instability)-High
- ClinicalTrials.gov ID
- NCT04695470
- Acronym / sponsor ID
- NCC2091
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aiping Zhou
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 Jan 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 prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.
Patients had to have received at least a second-line standard therapy, including fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial growth factor) inhibitors and to have disease progression within 3 months after the last administration of the last standard therapy or to have stopped such therapy due to unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were mandatory if RAS(Rat sarcoma virus) wild and left side .
Patients who met the eligibility criteria took fruquintinib plus Sintilimab until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival) rate at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib with Sintilimab | Experimental | Drug: Fruquintinib and SintilimabPatients who met the eligibility criteria took fruquintinib 5mg qd for 2 weeks on and 1 week off Q3w plus Sintilimab 200mg iv, Q3w. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Fully understand the study and signed the Informed Consent Form (ICF) out of their own will;
- Histologically or cytologically diagnosed with metastasis colorectal adenocarcinoma CRC (Phase IV)
- MSS or MSI-low, MSI was assessed per local guidelines (immunohistochemistry and/or polymerase chain reaction [PCR]) prior to screening. Tumor samples with instability in 0 or 1 marker were identified as microsatellite-stable and MSI-low, respectively.
- TMB≥5 mutations/Mb, TMB was performed on plasma samples by NGS.
- Subjects who failed at least second line standard chemotherapies including Fluorouracil, Oxaliplatin, Irinotecan and VEGF inhibitors(e.g., bevacizumab). Pre-treatment with anti-EGFR(e.g., cetuximab) were mandatory if RAS wild and left side. Failed therapies are defined as the occurance of PD or intolerable toxicities during the treatment or within 3 months after the last dose.
Key exclusion criteria (24 listed)
- with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
- Previous treatment with Fruquintinib or immune checkpoint inhibitors
- Absolute neutrophil count (ANC)<1.5×109/L, or blood platelet count (PLT)<100×109/L, or hemoglobin<90g/L; blood transfusion within 1 week before enrollment for the purpose of enrollment is not allowed;
- Serum total bilirubin>1.5×Upper Limit of Normal (ULN);Alanine transaminase(ALT) and/or Aspartate transferase (AST)>2.5×ULN (subject to the normal value at each site); or ALT and/or AST > 5×ULN for patients with liver metastases;
- Creatinineclearancerate< 50mL/min;
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 and Sintilimabfruquintinib 5mg qd for 2 weeks on and 1 week off, Q3w Sintilimab 200mg iv, Q3w | Drug | Fruquintinib with Sintilimab |
Primary outcome
PFS(progression free survival) rate at 6 months
Time frame: 6 months
To determine the clinical effectiveness of the study treatment assessed using PFS rate at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
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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?
A Phase 2 study testing Fruquintinib and Sintilimab in people with Colorectal Cancer, run by Aiping Zhou 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 24 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 7 Jan 2021. 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 Aiping Zhou, MD (8610-87788145, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS(progression free survival) rate at 6 months (time frame: 6 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 7 Jan 2021.