Colorectal NeoplasmsPhase 2NCT05372198
Surufatinib With or Wothout Immunotherapy for Advanced Colorectal Cancer in Later Line
A Phase 2 study testing Chohort 1: Surufatinib, Chohort 2: Immunotherapy and Chohort 2: Surufatinib in people with Colorectal Neoplasms, run by Hubei Cancer Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, cohort clinical study to investigate the efficacy and safety of surufatinib with or without immunotherapy in patients with advanced colorectal cancer who failed front-line anti-angiogenic TKI therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Chohort 1: Surufatinib, Chohort 2: Immunotherapy and Chohort 2: Surufatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent has been signed；
- Age ≥ 18 years, ≤80 years；
- Histologically confirmed advanced colorectal cancer；
- Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy)；
- ECOG 0-2；
- Life expectancy ≥ 12 weeks
- Patients must have adequate organ function；
- 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.
Who cannot join
- Have previously received surufatinib or immunotherapy;
- Have received other systemic anti-tumor therapies within 2 weeks(eg.chemotherapy or radiotherapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy);
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received major surgery within 4 weeks;
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- Pleural effusion or ascites causing relevant clinical symptoms , including respiratory syndrome (dyspnea≥CTC AE grade 2)；
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- Clinically significant electrolyte abnormality；
- Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 90mmHg regardless of any antihypertensive drugs；
- Patient currently has any disease or condition that affects drug absorption, or the patient cannot take surufatinib orally；
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI；
- Have evidence or history of bleeding tendency within 3 months or thromboembolic events within 12 months before enrollment;
- Clinically significant cardiovascular disease;
- Active or uncontrolled serious infection (≥CTCAE grade 2 infection);
- Clinical uncontrolled active infections, including human immunodeficiency virus (HIV) infection, active hepatitis B / C (HBV DNA Positive[1×104 copies/mL or >2000 IU/ml], HCV RNA positive[>1×103 copies/mL]);
- Patients have untreated central nervous system metastasis；
- Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a NCI CTCAE v5.0 Grade of 0 or 1, except for alopecia, lymphopenia, and neurotoxicity of grade ≤2 due to chemotherapeutic drugs;
- Pregnant or lactating women;
- Have received blood transfusion therapy, blood products and hematopoietic factors within 14 days;
- Proteinuria ≥ 2+ (1.0g/24hr);
- There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xu Huiting, M.D,, +86-15307176219, 2891533@qq.com
About this study
Official title: A Single-center, Open-label, Cohort Study of Surufatinib With or Without Immunotherapy in Patients With Advanced Colorectal Cancer Who Have Failed Front-line Antiangiogenic TKI Therapy
This is a single-center, open-label, cohort clinical study to investigate the efficacy and safety of surufatinib with or without immunotherapy in patients with advanced colorectal cancer who failed front-line anti-angiogenic TKI therapy.
Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy).
Patients who met the eligibility criteria are randomized 1:2 into two cohorts (cohort 1: surufatinib, cohort 2: surufatinib plus immunotherapy) to receive treatment 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).
- Conditions
- Colorectal Neoplasms
- Being tested
- Chohort 1: Surufatinib, Chohort 2: Immunotherapy, Chohort 2: Surufatinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chohort 1: SurufatinibDrug
Surufatinib 300mg, qd, every 3 weeks as a cycle
Chohort 2: ImmunotherapyDrug
Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle
Chohort 2: SurufatinibDrug
Surufatinib 250mg, qd, every 3 weeks as a cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Surufatinib Monotherapy | Experimental | Patients who met the eligibility criteria took Surufatinib 300mg qd, every 3 weeks as a cycle Receives: Drug: Chohort 1: Surufatinib |
| Cohort 2: Surufatinib with immunotherapy | Experimental | Patients who met the eligibility criteria took Surufatinib with immunotherapy:
Surufatinib:250mg qd, every 3 weeks as a cycle Immunotherapy: Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle Receives: Drug: Chohort 2: Immunotherapy; Drug: Chohort 2: Surufatinib |
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 enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: 36 months
Secondary outcomes (5)
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: 36 months
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 36 months
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: 36 months
quality of life (QoL) assessed by the QLQ-C30
QoL was defined as specific questionnaires can be used to evaluate the daily living ability of patients, so as to evaluate the effect of anti-tumor drug treatment In clinical research
Measured: 36 months
adverse events (AE)
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start30 Mar 2022
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAN GUANG, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372198
- Sponsor's protocol ID
- LCKY2021030
- Status last verified
- Nov 2022
- First submitted
- 9 May 2022
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Cohort Study of Surufatinib With or Without Immunotherapy in Patients With Advanced Colorectal Cancer Who Have Failed Front-line Antiangiogenic TKI Therapy
- ClinicalTrials.gov ID
- NCT05372198
- Acronym / sponsor ID
- LCKY2021030
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 May 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 is a single-center, open-label, cohort clinical study to investigate the efficacy and safety of surufatinib with or without immunotherapy in patients with advanced colorectal cancer who failed front-line anti-angiogenic TKI therapy.
Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy).
Patients who met the eligibility criteria are randomized 1:2 into two cohorts (cohort 1: surufatinib, cohort 2: surufatinib plus immunotherapy) to receive treatment 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Surufatinib Monotherapy | Experimental | Drug: Chohort 1: SurufatinibPatients who met the eligibility criteria took Surufatinib 300mg qd, every 3 weeks as a cycle |
| Cohort 2: Surufatinib with immunotherapy | Experimental | Drug: Chohort 2: Immunotherapy, Drug: Chohort 2: SurufatinibPatients who met the eligibility criteria took Surufatinib with immunotherapy: Surufatinib:250mg qd, every 3 weeks as a cycle Immunotherapy: Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent has been signed；
- Age ≥ 18 years, ≤80 years；
- Histologically confirmed advanced colorectal cancer；
- Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy)；
- ECOG 0-2；
Key exclusion criteria (20 listed)
- Have previously received surufatinib or immunotherapy;
- Have received other systemic anti-tumor therapies within 2 weeks(eg.chemotherapy or radiotherapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy);
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received major surgery within 4 weeks;
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
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 |
|---|---|---|
| Chohort 1: SurufatinibSurufatinib 300mg, qd, every 3 weeks as a cycle | Drug | Cohort 1: Surufatinib Monotherapy |
| Chohort 2: ImmunotherapyRefer to the instructions for the use of immunotherapy, every 3 weeks as a cycle | Drug | Cohort 2: Surufatinib with immunotherapy |
| Chohort 2: SurufatinibSurufatinib 250mg, qd, every 3 weeks as a cycle | Drug | Cohort 2: Surufatinib with immunotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 36 months
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
5 secondary outcomes
overall survival (OS)
Time frame: 36 months
objective response rate (ORR)
Time frame: 36 months
disease control rate (DCR)
Time frame: 36 months
quality of life (QoL) assessed by the QLQ-C30
Time frame: 36 months
adverse events (AE)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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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 Chohort 1: Surufatinib, Chohort 2: Immunotherapy and Chohort 2: Surufatinib in people with Colorectal Neoplasms, run by Hubei Cancer 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 8 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 9 Nov 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 Xu Huiting, M.D. (+86-15307176219, 2891533@qq.com), 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: 36 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 9 Nov 2022.