Metastatic Colorectal CancerPhase 2NCT04194359
Sintilimab (IBI308) Combined With Bevacizumab + XELOX Regimen in Metastatic Colorectal Cancer
A Phase 2 study testing Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine in people with Metastatic Colorectal Cancer and RAS Mutation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A phase II clinical study of Sintilimab (IBI308) combined with Bevacizumab, Oxaliplatin and Capecitabine regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. A total of 25 patients are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer, RAS Mutation, Microsatellite Stable
- What is being tested?
- Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 12 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years old, ≤ 75 years old;
- Metastatic colorectal adenocarcinoma confirmed by histology and unresectable metastatic colorectal cancer confirmed by a multidisciplinary team;
- RAS gene mutation, BRAF wild-type and microsatellite stable confirmed by polymerase chain reaction using a panel of six mononucleotide repeat markers (BAT-25, BAT-26, NR-21, NR-24, NR-27, and MONO-27);
- ECOG performance status of 0-1;
- Life expectancy≥3 months;
- Adequate organ and bone marrow functions: absolute neutrophil count >1.5×109/L, hemoglobin >8 g/dL, platelet count >100×109/L, prothrombin time <1.5 upper limit of normal (ULN), activated partial thromboplastin time <1.5 ULN, bilirubin ≤1.5×ULN (could be extended to 3×ULN in case of liver metastasis), blood aspartate aminotransferase and alanine aminotransferase ≤2.5×ULN (could be extended to 5×ULN in case of liver metastasis), serum creatinine level ≤1.5×ULN or creatinine clearance ≥50 mL/min, urinary protein / creatinine ratio < 1 (or urine analysis < 1 + or 24-hour urinary protein < 1g / 24 h;
- Informed consent has been signed;
- The presence of at least one measurable lesion assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Who cannot join
- received previous treatment with any anti-programmed cell death protein 1 (PD-1) or anti-PD-L1 antibody;
- received treatment with corticosteroids or other immunosuppressive agents within 14 days prior to study drug administration;
- presence of autoimmune disease, known interstitial lung disease;
- those with previous or concurrent malignancies expect for basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ that have undergone radical treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Evaluation on the Tolerance and Preliminary Efficacy of Sintilimab (IBI308) Combined With Bevacizumab, Oxaliplatin and Capecitabine Regimen for Ras Gene Mutant and Microsatellite Stable Unresectable Metastatic Colorectal Cancer
A phase II clinical study of Sintilimab (IBI308) combined with Bevacizumab, Oxaliplatin and Capecitabine regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. A total of 25 patients are planned to be enrolled.
Read the detailed description
This study is a phase II clinical study of Sintilimab (IBI308) combined with bevacizumab + XELOX regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. The study treatment took 21 days as a treatment cycle. Sintilimab (IBI308), bevacizumab and oxaliplatin were given intravenously on the first day of each cycle, and capecitabine was given from the first day to the 14th day. All adverse events will be graded according to NCI CTCAE (version 5.0). Up to 8 courses of inductive therapy would be given. During the treatment, CT was rechecked every 2 courses to evaluate the curative effect. Patients with objective response or stable disease (SD) would continue to receive sintilimab plus bevacizumab and oral capecitabine in each 21-day cycle as maintenance therapy until the confirmation of disease progression, death, unacceptable toxicity, or withdrawal of consent.
A total of 25 patients are planned to be enrolled. When the number of subjects reaches 25 respectively, the enrollment ends to inquire about the safety and efficacy of Sintilimab (IBI308) combined with bevacizumab + XELOX.
- Being tested
- Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine
- Keywords
- RAS-mutant Metastatic Colorectal Cancer, Immunotherapy, Anti-PD-1, Checkpoint, Efficacy, Safety, 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.
Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabineDrug
Humanized PD-1 antibody (Sintilimab, IBI308)+bevacizumab+oxaliplatin+capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine | Experimental | Sintilimab (IBI308)：200MG, once every three weeks; Bevacizumab:7.5mg/kg, once every three weeks; oxplatin: 135 mg per square meter body surface, once every three weeks; Capecitabine : Capecitabine 1 gram per square meter body surface area, from the first day to the 14th day Receives: Drug: Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).
Measured: From Baseline to disease progress, up to 18 months
Adverse Events and Serious Adverse Events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Measured: From Baseline to primary completion date, about 2 years
Secondary outcomes (2)
Disease Control Rate
Disease Control Rate was defined as the proportion of patients with CR, PR, or SD according to RECIST criteria (version 1.1)
Measured: From Baseline to disease progress, up to 18 months
Progression free survival
Progression-free survival is defined as the time from enrollment to the first documented disease progression according to RECIST version 1.1, or to death from any cause, whichever occurred first.
Measured: From Baseline to primary completion date, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start4 Feb 2021
- Primary completion30 Nov 2022
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Yuan, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194359
- Sponsor's protocol ID
- 2020-552
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2019
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang X, Zhu N, Zhong C, Wang L, Li J, Weng S, Hu H, Dong C, Li D, Song Y, Xu D, Wang J, Sun L, Wang J, Wang Z, Cao H, Liao X, Yu N, Xiao Q, Mi M, Zhang S, Ding K, Yuan Y. Sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line therapy in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer: an open-label, single-arm, phase II trial. EClinicalMedicine. 2023 Jul 27;62:102123. doi: 10.1016/j.eclinm.2023.102123. eCollection 2023 Aug.
PubMed 37554125
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Tolerance and Preliminary Efficacy of Sintilimab (IBI308) Combined With Bevacizumab, Oxaliplatin and Capecitabine Regimen for Ras Gene Mutant and Microsatellite Stable Unresectable Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04194359
- Acronym / sponsor ID
- 2020-552
- Keywords
- RAS-mutant Metastatic Colorectal Cancer, Immunotherapy, Anti-PD-1, Checkpoint, Efficacy, Safety, Microsatellite stable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 11 Dec 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.
A phase II clinical study of Sintilimab (IBI308) combined with Bevacizumab, Oxaliplatin and Capecitabine regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. A total of 25 patients are planned to be enrolled.
Detailed description
This study is a phase II clinical study of Sintilimab (IBI308) combined with bevacizumab + XELOX regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. The study treatment took 21 days as a treatment cycle. Sintilimab (IBI308), bevacizumab and oxaliplatin were given intravenously on the first day of each cycle, and capecitabine was given from the first day to the 14th day. All adverse events will be graded according to NCI CTCAE (version 5.0). Up to 8 courses of inductive therapy would be given. During the treatment, CT was rechecked every 2 courses to evaluate the curative effect. Patients with objective response or stable disease (SD) would continue to receive sintilimab plus bevacizumab and oral capecitabine in each 21-day cycle as maintenance therapy until the confirmation of disease progression, death, unacceptable toxicity, or withdrawal of consent.
A total of 25 patients are planned to be enrolled. When the number of subjects reaches 25 respectively, the enrollment ends to inquire about the safety and efficacy of Sintilimab (IBI308) combined with bevacizumab + XELOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine | Experimental | Drug: Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabineSintilimab (IBI308)：200MG, once every three weeks; Bevacizumab:7.5mg/kg, once every three weeks; oxplatin: 135 mg per square meter body surface, once every three weeks; Capecitabine : Capecitabine 1 gram per square meter body surface area, from the first day to the 14th day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age ≥ 18 years old, ≤ 75 years old;
- Metastatic colorectal adenocarcinoma confirmed by histology and unresectable metastatic colorectal cancer confirmed by a multidisciplinary team;
- RAS gene mutation, BRAF wild-type and microsatellite stable confirmed by polymerase chain reaction using a panel of six mononucleotide repeat markers (BAT-25, BAT-26, NR-21, NR-24, NR-27, and MONO-27);
- ECOG performance status of 0-1;
- Life expectancy≥3 months;
Key exclusion criteria (4 listed)
- received previous treatment with any anti-programmed cell death protein 1 (PD-1) or anti-PD-L1 antibody;
- received treatment with corticosteroids or other immunosuppressive agents within 14 days prior to study drug administration;
- presence of autoimmune disease, known interstitial lung disease;
- those with previous or concurrent malignancies expect for basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ that have undergone radical treatment.
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 |
|---|---|---|
| Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabineHumanized PD-1 antibody (Sintilimab, IBI308)+bevacizumab+oxaliplatin+capecitabine | Drug | Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine |
Primary outcome
Objective Response Rate
Time frame: From Baseline to disease progress, up to 18 months
Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).
Adverse Events and Serious Adverse Events
Time frame: From Baseline to primary completion date, about 2 years
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
2 secondary outcomes
Disease Control Rate
Time frame: From Baseline to disease progress, up to 18 months
Progression free survival
Time frame: From Baseline to primary completion date, about 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 37554125Fang X, Zhu N, Zhong C, Wang L, Li J, Weng S, Hu H, Dong C, Li D, Song Y, Xu D, Wang J, Sun L, Wang J, Wang Z, Cao H, Liao X, Yu N, Xiao Q, Mi M, Zhang S, Ding K, Yuan Y. Sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line therapy in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer: an open-label, single-arm, phase II trial. EClinicalMedicine. 2023 Jul 27;62:102123. doi: 10.1016/j.eclinm.2023.102123. eCollection 2023 Aug.
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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.
Ying Yuan, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine in people with Metastatic Colorectal Cancer and RAS Mutation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From Baseline to disease progress, up to 18 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?
On the ClinicalTrials.gov record for NCT04194359, which also lists 1 linked publication.
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 Mar 2023.