Colorectal Cancer MetastaticPhase 2NCT04030260
Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer
A Phase 2 study testing Regorafenib and PD-1 antibody in Combination with Radiotherapy and Radiation therapy in people with Colorectal Cancer Metastatic and MSS, run by Sun Yat-sen University at 1 site in China.
Trial summary
REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer Metastatic, MSS
- What is being tested?
- Regorafenib and PD-1 antibody in Combination with Radiotherapy and Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2019to 19 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- Subjects with metastatic colorectal cancer(CRC) (Stage IV).
- Subjects must have failed at least two lines of prior treatment.
- Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
- Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
- Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
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- Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
- Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
- Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)
- Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Who cannot join
- Prior treatment with Regorafenib.
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
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- Pleural effusion or ascites that causes respiratory compromise.
- Arterial or venous thrombotic or embolic events.
- Any history of or currently known brain metastases.
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, M.D., 86-13925106525, 13925106525@163.com
About this study
Official title: Regorafenib and PD-1 Antibody in Combination With Radiotherapy With or Without SBRT in Patients With pMMR/MSS and Previously Treated Metastatic Colorectal Cancer
REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months.
Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and PD-1 antibody with or without radiotherapy in previously treated metastatic colorectal cancer patients with pMMR/MSS.
- Conditions
- Colorectal Cancer Metastatic, MSS
- Being tested
- Regorafenib and PD-1 antibody in Combination with Radiotherapy, Radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib and PD-1 antibody in Combination with RadiotherapyDrug
Also called Regorafenib, PD-1 antibody
Regorafenib will be given 3 weeks on/1 week off (80 mg od po.) and PD-1 antibody
Radiation therapyRadiation
Radiation therapy is believed to increase the likelihood of response of immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib and PD-1 antibody in Combination with Radiotherapy | Experimental | Not described Receives: Drug: Regorafenib and PD-1 antibody in Combination with Radiotherapy; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression-free survival (PFS) rates at 6 months
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment. The PFS rates at 6 months was estimated from Kaplan-Meier curves.
Measured: 2 year
Secondary outcomes (4)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Measured: 2 year
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Measured: 2 year
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Measured: 2 year
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Jul 2019
- Primary completion20 Feb 2023
- Study completion19 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Yanhong Deng, M.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030260
- Sponsor's protocol ID
- GIHSYSU-16
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib and PD-1 Antibody in Combination With Radiotherapy With or Without SBRT in Patients With pMMR/MSS and Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04030260
- Acronym / sponsor ID
- GIHSYSU-16
- Conditions
- Colorectal Cancer Metastatic, MSS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 19 Jul 2023 (estimated)
- First posted
- 23 Jul 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.
REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months.
Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and PD-1 antibody with or without radiotherapy in previously treated metastatic colorectal cancer patients with pMMR/MSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib and PD-1 antibody in Combination with Radiotherapy | Experimental | Drug: Regorafenib and PD-1 antibody in Combination with Radiotherapy, Radiation: Radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- Subjects with metastatic colorectal cancer(CRC) (Stage IV).
- Subjects must have failed at least two lines of prior treatment.
- Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
- Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
Key exclusion criteria (11 listed)
- Prior treatment with Regorafenib.
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
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 antibody in Combination with RadiotherapyAlso: Regorafenib, PD-1 antibodyRegorafenib will be given 3 weeks on/1 week off (80 mg od po.) and PD-1 antibody | Drug | Regorafenib and PD-1 antibody in Combination with Radiotherapy |
| Radiation therapyRadiation therapy is believed to increase the likelihood of response of immunotherapy | Radiation | Regorafenib and PD-1 antibody in Combination with Radiotherapy |
Primary outcome
The progression-free survival (PFS) rates at 6 months
Time frame: 2 year
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment. The PFS rates at 6 months was estimated from Kaplan-Meier curves.
4 secondary outcomes
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time frame: 2 year
Overall Survival (OS)
Time frame: 2 year
Disease Control Rate (DCR)
Time frame: 2 year
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- 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.
Yanhong Deng, M.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 Regorafenib and PD-1 antibody in Combination with Radiotherapy and Radiation therapy in people with Colorectal Cancer Metastatic and MSS, 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 13 inclusion and 11 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 23 Mar 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 Yanhong Deng, M.D. (86-13925106525, 13925106525@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression-free survival (PFS) rates at 6 months (time frame: 2 year). 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 23 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.