Locally Advanced Rectal CancerPhase 2NCT04989855
Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score
A Phase 2 study testing Fruquintinib plus Tislelizumab in people with Locally Advanced Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Fruquintinib plus Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 yrs old;
- pMMR/MSS rectal adenocarcinoma;
- Pelvic MRI / endoscopic ultrasonography or transrectal ultrasound were used for reoperative staging: T3-4N+ with resectable tumor;
- High immune score (Immunoscore®️ ≥3);
- No sign of bowel obstruction, or bowel obstruction has been relieved by ostomy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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- No previous chemotherapy, radiotherapy or immunotherapy;
- Distant metastasis was excluded by CT of chest, abdomen and pelvis before operation;
- Able to swallow tablets;
- Life expectancy of at least 2 years;
- Adequate organ function;
- Female participants of childbearing potential must be willing to use adequate contraception for the course of the study starting with the first dose of study medication through 120 days after the last PD-1 antibody dose; Male participants must agree to use adequate contraception for the course of the study starting with the first dose of study medication through 120 days after the last PD-1 antibody dose.
Who cannot join
- Any active autoimmune disease or history of autoimmune disease;
- Immunosuppressants, systemic or absorbable local hormones are being used to achieve the purpose of immunosuppression (dose > 10mg / day, prednisone or other effective hormones) and continue to be used within 2 weeks before enrollment;
- History of severe allergic reaction to monoclonal antibody;
- Subjects with untreated active brain metastasis or meningeal metastasis with clinical symptoms;
- Suffering from hypertension and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg);
- Have previously received other PD-1 antibody therapy or other immunotherapy against PD-1 / PD-L1, or have previously received anti angiogenesis drugs;
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- There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or undergoing thrombolytic or anticoagulant therapy;
- Urine routine examination indicates that urinary protein is ≥ + +, or confirmed 24-hour urinary protein is ≥ 1.0g;
- Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before enrollment, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood + + or above, or vasculitis;
- Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- Subjects with active infection;
- Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis B: HBsAg positive and HBV DNA > 104 copy number /ml; Hepatitis C: HCV antibody positive);
- Those who participated in clinical trials of other drugs within 3 months before enrollment;
- There was evidence of distant metastasis before operation;
- History of pelvic or abdominal radiotherapy;
- Any other malignant disease within the preceding 5 years with the exception of cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer;
- Live vaccines were administered less than 4 weeks before the study or possibly during the study period;
- Known or suspected allergy to the study drug or to any drug given in connection with this test;
- In the judgment of the researcher, the subject has other circumstances that may affect the results of the study or cause the study to be forced to stop halfway.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fruquintinib Combined With PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score: an Open-label, Multi-center, Phase II Clinical Trial
This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.
Read the detailed description
48 patients of pMMR / MSS locally advanced rectal cancer with high immune score will be administered with tislelizumab (200mg IV d1, Q3W ) combined with fruquintinib (5mg QD d1-d14, Q3W) with a total of 2 cycles as neoadjuvant therapy. After TME, tislelizumab and fruquintinib will be given again for up to 6 months as adjuvant therapy. If the patient after neoadjuvant therapy is evaluated as SD/PD, the neoadjuvant therapy will be converted to neoadjuvant chemo-radiotherapy/chemotherapy or palliative therapy, and then the patient will be treated according to the norms of adjuvant therapy for rectal cancer if TME is performed. If the patient choose Watch \& Wait when evaluated as CR, tislelizumab plus fruquintinib for at least one year is requested.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Fruquintinib plus Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib plus TislelizumabDrug
2 cycles of Fruquintinib(F) 5mg QD d1-d14 + Tislelizumab(T) 200mg IV d1, Q3W as preoperative therapy, and F +T after TME as postoperative therapy for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib plus Tislelizumab | Experimental | Fruquintinib 5mg QD d1-d14, Q3W; Tislelizumab 200mg IV Q3W d1 Receives: Drug: Fruquintinib plus Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: up to 3 years
Secondary outcomes (3)
3-year RFS
3-year relapse-free survival
Measured: up to 3 years
3-year OS
3-year overall survival
Measured: up to 3 years
Safety and Tolerability
treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989855
- Sponsor's protocol ID
- HMPL-013-FLAG-C105
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 4 Aug 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 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined With PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score: an Open-label, Multi-center, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04989855
- Acronym / sponsor ID
- HMPL-013-FLAG-C105
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 4 Aug 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, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.
Detailed description
48 patients of pMMR / MSS locally advanced rectal cancer with high immune score will be administered with tislelizumab (200mg IV d1, Q3W ) combined with fruquintinib (5mg QD d1-d14, Q3W) with a total of 2 cycles as neoadjuvant therapy. After TME, tislelizumab and fruquintinib will be given again for up to 6 months as adjuvant therapy. If the patient after neoadjuvant therapy is evaluated as SD/PD, the neoadjuvant therapy will be converted to neoadjuvant chemo-radiotherapy/chemotherapy or palliative therapy, and then the patient will be treated according to the norms of adjuvant therapy for rectal cancer if TME is performed. If the patient choose Watch \& Wait when evaluated as CR, tislelizumab plus fruquintinib for at least one year is requested.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib plus Tislelizumab | Experimental | Drug: Fruquintinib plus TislelizumabFruquintinib 5mg QD d1-d14, Q3W; Tislelizumab 200mg IV Q3W d1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-75 yrs old;
- pMMR/MSS rectal adenocarcinoma;
- Pelvic MRI / endoscopic ultrasonography or transrectal ultrasound were used for reoperative staging: T3-4N+ with resectable tumor;
- High immune score (Immunoscore®️ ≥3);
- No sign of bowel obstruction, or bowel obstruction has been relieved by ostomy;
Key exclusion criteria (20 listed)
- Any active autoimmune disease or history of autoimmune disease;
- Immunosuppressants, systemic or absorbable local hormones are being used to achieve the purpose of immunosuppression (dose > 10mg / day, prednisone or other effective hormones) and continue to be used within 2 weeks before enrollment;
- History of severe allergic reaction to monoclonal antibody;
- Subjects with untreated active brain metastasis or meningeal metastasis with clinical symptoms;
- Suffering from hypertension and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg);
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 Tislelizumab2 cycles of Fruquintinib(F) 5mg QD d1-d14 + Tislelizumab(T) 200mg IV d1, Q3W as preoperative therapy, and F +T after TME as postoperative therapy for 6 months | Drug | Fruquintinib plus Tislelizumab |
Primary outcome
ORR
Time frame: up to 3 years
Objective Response Rate
3 secondary outcomes
3-year RFS
Time frame: up to 3 years
3-year OS
Time frame: up to 3 years
Safety and Tolerability
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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 plus Tislelizumab in people with Locally Advanced Rectal Cancer, run by Sun Yat-sen University 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 20 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 4 Aug 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 Pei-Rong Ding, M.D. (8602087343920, dingpr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 years). 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 Aug 2021.