Metastatic Colorectal CancerPhase 2NCT05438108
SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in First-line Treatment of mCRC
A Phase 2 study testing SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in people with Metastatic Colorectal Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Age ≥ 18 years, ≤75 years;
- Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer,metastases cannot be removed;
- No prior systemic treatment for advanced or metastatic colorectal cancer (including chemical therapy, epidermal growth factor receptor inhibitors such as cetuximab or panizumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies and anti-CTLA-4 antibodies);
- The interval between adjuvant or neoadjuvant chemotherapy is more than one year;
- According to the definition of RECIST 1.1, the investigator determined that the patient had at least one measurable disease;
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- At least one lesion is suitable for SBRT according to the evaluation of the researchers;
- Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be enrolled as long as they meet the following conditions:
- 1) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks; 3) no glucocorticoid treatment or discontinuation of glucocorticoid treatment within 7 days prior to administration of the first study drug;
- 9.ECOG 0-1;
- 10. Life expectancy >3 months;
- 11. LVEF ≥50%;
- 12.Adequate organ function, subject will meet the following laboratory criteria:
- Absolute value of neutrophil (ANC) ≥1.5x109/L.
- Platelet ≥90×109/L.
- Hemoglobin≥ 9 g/dL.
- Total bilirubin ≤1.5× upper normal value (ULN); Or total bilirubin \& GT; ULN but direct bilirubin ≤ ULN;
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);
- Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60 mL /min;
- Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN;
- Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled;
- Urinary protein <2 +; If urine protein ≥2+, the 24-hour urine protein quantification must be ≤1g.
- 13.Women of childbearing age must be willing to use adequate contraception during study drug therapy.
Who cannot join
- Prior treatment with anti-PD-L1, anti-PD-L2 drugs, or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137);
- Symptomatic or high-risk obstruction, bleeding, perforation, pneumonia (including noninfectious pneumonia with prior hormone therapy and pneumonia patients under treatment), etc;
- Other malignant diseases other than colorectal cancer were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ);
- Subject is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic;
- Subjects were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to study initial dosing;
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- Active hemoptysis (cough up at least 2.5ml or 1/2 teaspoon blood at a time) within 3 months prior to administration of the drug in the first study;
- Imaging shows tumor invasion/invasion of large vessels or bleeding tendency as assessed by investigator or radiologist;
- Had major surgery within 4 weeks prior to administration of the first study drug (except for surgery for biopsy purposes) or expected to have major surgery during the study period;
- Severe unhealed wounds, ulcers or fractures;
- Current or recent use of aspirin (within 10 days prior to receiving the first study dose) for 10 consecutive days (> 325 mg/ day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function; Current or recent (within 10 days prior to receiving the first study dose) treatment with a full-dose oral or parenteral anticoagulant or thrombolysis agent for 10 consecutive days;
- Hereditary bleeding tendency or coagulopathy;
- Digestive diseases such as active gastrointestinal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation
- Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known;
- Known allergy to oxaliplatin, capecitabine, sindilizumab or bevacizumab active ingredients or excipients;
- Patients with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- Has not fully recovered from toxicity and/or complications associated with any intervention prior to initiation of treatment (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Untreated active hepatitis B;
- Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);
- Received live vaccine within 30 days prior to initial administration (cycle 1, day 1);
- Note: Acceptance of injectable inactivated virus vaccine against seasonal influenza is permitted within 30 days prior to first administration; Intranasally administered live attenuated flu vaccines are not allowed.
- Pregnant or lactating women;
- Grade II or above peripheral neuropathy according to NCI CTCAE standards;
- Patients undergoing strong CYP3A4 inducers;
- The presence of any serious or uncontrollable systemic disease;
- Any medical history or disease evidence that may interfere with the study results, prevent the subjects from participating fully in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers inappropriate for the study because of other potential risks that the investigator considers inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xianglin Yuan
Wuhan, Hubei, 430030
Xianglin Yuan, +8613667241722, yuanxianglin@hust.edu.cn
About this study
Official title: An Open, Single-arm, Exploratory Study of SBRT Sequential CapeOX Chemotherapy Combined With Bevacizumab and Sintilimab in First-line Treatment of Metastatic Colorectal Cancer
Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. This is a prospective, single-arm study to explore the efficacy and safety of SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab in treatment with patients with initially unresectable advanced colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab
- Keywords
- mCRC, SBRT, chemotherapy, immune checkpoint inhibitor
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT Sequential CapeOX Regimen Combined With Bevacizumab and SintilimabCombination product
SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab
| Study group | Role | What they receive |
|---|---|---|
| SBRT sequential chemotherapy, bevacizumab and sitilimab | Experimental | Not described Receives: Combination Product: SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
AEs
Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.
Measured: up to 36 months
Secondary outcomes (3)
Disease control rate (DCR)
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Progression-free survival (PFS)
To assess the efficacy of Tislelizumab Combined With Fruquintinib and SBRT for patients with advanced colorectal cancer by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: up to 18 months
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Model description
- SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438108
- Sponsor's protocol ID
- TJCC013
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Exploratory Study of SBRT Sequential CapeOX Chemotherapy Combined With Bevacizumab and Sintilimab in First-line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05438108
- Acronym / sponsor ID
- TJCC013
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC, SBRT, chemotherapy, immune checkpoint inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 29 Jun 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.
Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. This is a prospective, single-arm study to explore the efficacy and safety of SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab in treatment with patients with initially unresectable advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab
| Arm | Type | Receives |
|---|---|---|
| SBRT sequential chemotherapy, bevacizumab and sitilimab | Experimental | Combination Product: SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Age ≥ 18 years, ≤75 years;
- Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer,metastases cannot be removed;
- No prior systemic treatment for advanced or metastatic colorectal cancer (including chemical therapy, epidermal growth factor receptor inhibitors such as cetuximab or panizumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies and anti-CTLA-4 antibodies);
- The interval between adjuvant or neoadjuvant chemotherapy is more than one year;
Key exclusion criteria (27 listed)
- Prior treatment with anti-PD-L1, anti-PD-L2 drugs, or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137);
- Symptomatic or high-risk obstruction, bleeding, perforation, pneumonia (including noninfectious pneumonia with prior hormone therapy and pneumonia patients under treatment), etc;
- Other malignant diseases other than colorectal cancer were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ);
- Subject is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic;
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 |
|---|---|---|
| SBRT Sequential CapeOX Regimen Combined With Bevacizumab and SintilimabSBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab | Combination product | SBRT sequential chemotherapy, bevacizumab and sitilimab |
Primary outcome
Objective response rate (ORR)
Time frame: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
AEs
Time frame: up to 36 months
Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.
3 secondary outcomes
Disease control rate (DCR)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 18 months
Overall survival (OS)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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CRC
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 SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in people with Metastatic Colorectal Cancer, run by Huazhong University of Science and Technology 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 23 inclusion and 27 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 29 Jun 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 Xianglin Yuan (+8613667241722, yuanxianglin@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 12 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 29 Jun 2022.