Colorectal CancerPhase 2NCT04653480
Surufatinib, Toripalimab and Chemotherapy in Second-line MT and MSS CRC
A Phase 2 study testing Surufatinib, Toripalimab and chemotherapy in people with Colorectal Cancer, run by Zhejiang University at 1 site in China.
Trial summary
To determine the efficacy and safety of surufatinib, toripalimab and chemotherapy in second-line RAS/BRAF mutant and MSS colorectal cancer 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?
- Surufatinib, Toripalimab and chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Jun 2025
- 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
- Age ≥ 18 years, ≤75 years
- Histologically confirmed colorectal cancer with distant metastasis.
- ECOG 0-1
- Progression on first line therapy
- RAS/BRAF mutant and microsatellite stable
- Patients can swallow pills normally
Show all 13Show fewer
- Expected overall survival ≥6 months
- Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.
- AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
- Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
- Patients who have not received immunotherapy
- Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;
- Informed consent has been signed.
Who cannot join
- Patients have received ≥2 line systemic therapy;
- Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
- Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed.
- Certain or suspected brain metastases.
- The patient has a history of autoimmune disease.
- Serious uncontrolled systemic diseases, such as severe active infections;
Show all 18Show fewer
- A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
- Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA >500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) may be enrolled
- Anti-infective therapy was not discontinued 14 days before the study;
- A prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, and symptomatic interstitial lung disease or the presence of active pneumonia on a chest CT scan within 4 weeks prior to the study.
- Patients have a history of intestinal obstruction within six months. Patients with incomplete obstruction syndrome of ileus at the time of initial diagnosis may be enrolled in the study if they have received definitive (surgical) treatment to resolve the symptoms, as assessed by the investigator.
- Patients Have high blood pressure that cannot be well controlled by antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein >1.0g;
- Known to be allergic to any study drug;
- Patients have participated in other drug clinical studies within 4 weeks before enrollment;
- Lactating women
- According to the judgment of the researcher, the patient may have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
Weijia fang, MD
Weijia fang, MD
About this study
Official title: Surufatinib and Toripalimab Combined With Chemotherapy for Second-line Treatment of Advanced RAS/BRAF Mutant and Microsatellite Stable Colorectal Cancer
To determine the efficacy and safety of surufatinib, toripalimab and chemotherapy in second-line RAS/BRAF mutant and MSS colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Surufatinib, Toripalimab, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
250mg per oral, once daily
ToripalimabDrug
3mg/kg IV, once every 2 weeks
chemotherapyDrug
oxaliplatin or irinotecan based regimens, according to the first line treatment
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib, Toripalimab and Chemotherapy | Experimental | Second line CRC patients received surufatinib 250mg po qd , toripalimab 3mg/kg ivgtt q2w and chemotherapy according to the first line treatment, until disease progression or intolerable toxicity Receives: Drug: Surufatinib; Drug: Toripalimab; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug. ORR is generally defined as the sum of complete responses (CRs) - patients with no detectable evidence of a tumor over a specified time period - and partial responses (PRs) - patients with a decrease in tumor size over a specified time period.
Measured: 2 months
Secondary outcomes (2)
Overall Survival
Refers to the time of death from enrollment to any cause
Measured: 2 years
Progression Free Survival
the time elapsed between treatment initiation and tumor progression
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 posted4 Dec 2020
- Study start1 Feb 2021
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (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.
- More trials run by Zhejiang 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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653480
- Sponsor's protocol ID
- APHRODITE
- Status last verified
- Jul 2023
- First submitted
- 28 Nov 2020
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surufatinib and Toripalimab Combined With Chemotherapy for Second-line Treatment of Advanced RAS/BRAF Mutant and Microsatellite Stable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04653480
- Acronym / sponsor ID
- APHRODITE
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Dec 2020 (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.
To determine the efficacy and safety of surufatinib, toripalimab and chemotherapy in second-line RAS/BRAF mutant and MSS colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib, Toripalimab and Chemotherapy | Experimental | Drug: Surufatinib, Drug: Toripalimab, Drug: chemotherapySecond line CRC patients received surufatinib 250mg po qd , toripalimab 3mg/kg ivgtt q2w and chemotherapy according to the first line treatment, until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years, ≤75 years
- Histologically confirmed colorectal cancer with distant metastasis.
- ECOG 0-1
- Progression on first line therapy
- RAS/BRAF mutant and microsatellite stable
Key exclusion criteria (18 listed)
- Patients have received ≥2 line systemic therapy;
- Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
- Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed.
- Certain or suspected brain metastases.
- The patient has a history of autoimmune disease.
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 |
|---|---|---|
| Surufatinib250mg per oral, once daily | Drug | Surufatinib, Toripalimab and Chemotherapy |
| Toripalimab3mg/kg IV, once every 2 weeks | Drug | Surufatinib, Toripalimab and Chemotherapy |
| chemotherapyoxaliplatin or irinotecan based regimens, according to the first line treatment | Drug | Surufatinib, Toripalimab and Chemotherapy |
Primary outcome
Overall Response Rate
Time frame: 2 months
the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug. ORR is generally defined as the sum of complete responses (CRs) - patients with no detectable evidence of a tumor over a specified time period - and partial responses (PRs) - patients with a decrease in tumor size over a specified time period.
2 secondary outcomes
Overall Survival
Time frame: 2 years
Progression Free Survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 Surufatinib, Toripalimab and chemotherapy in people with Colorectal Cancer, run by Zhejiang 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 13 inclusion and 18 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 17 Jul 2023. 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 Weijia Fang, MD. (+86-571-87235147, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 2 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 17 Jul 2023.