Colorectal CancerPhase 1/2NCT04110093
Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
A Phase 1/2 study testing Regorafenib and PD-1 inhibitor in people with Colorectal Cancer and Immunotherapy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Immunotherapy
- What is being tested?
- Regorafenib and PD-1 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Aug 2021
- Phase
- Phase 1/2
- 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
- Advanced Colorectal Cancer diagnosed histologically;
- Patients with microsatellite stable (MSS)
- Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);
- Expected survival ≥ 3 month;
- ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
Who cannot join
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai
Zhan Wang, +86-13916229609, 13916229609@139.com
Yuan-Sheng Zang
About this study
Official title: The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients
This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).
- Conditions
- Colorectal Cancer, Immunotherapy
- Being tested
- Regorafenib and PD-1 inhibitor
- Keywords
- Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib and PD-1 inhibitorDrug
All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy Combination treatment | Experimental | All colorectal cancer patients received regorafenib plus PD-1 inhibitor Receives: Drug: Regorafenib and PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Progress Free Survival
Time from treatment beginning until disease progression
Measured: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Secondary outcomes (2)
Overall Survival
Time from treatment beginning until death from any cause
Measured: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Incidence of Treatment-related adverse Events
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (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 Shanghai Changzheng HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Sheng Zang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110093
- Sponsor's protocol ID
- CZ-REGONIVO
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2019
- Last updated
- 30 Dec 2020
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04110093
- Acronym / sponsor ID
- CZ-REGONIVO
- Conditions
- Colorectal Cancer, Immunotherapy
- Keywords
- Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Oct 2019 (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 is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy Combination treatment | Experimental | Drug: Regorafenib and PD-1 inhibitorAll colorectal cancer patients received regorafenib plus PD-1 inhibitor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced Colorectal Cancer diagnosed histologically;
- Patients with microsatellite stable (MSS)
- Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);
- Expected survival ≥ 3 month;
- ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
Key exclusion criteria (2 listed)
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
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 |
|---|---|---|
| Regorafenib and PD-1 inhibitorAll Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w). | Drug | Immunotherapy Combination treatment |
Primary outcome
Objective Response Rate
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Progress Free Survival
Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Time from treatment beginning until disease progression
2 secondary outcomes
Overall Survival
Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Time frame: Through study completion, an average of 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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.
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regorafenib and PD-1 inhibitor in people with Colorectal Cancer and Immunotherapy, run by Shanghai Changzheng 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 5 inclusion and 2 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 30 Dec 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months). The study lists 2 primary outcomes in all. 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 30 Dec 2020.