Colorectal CancerNCT05544812
A Small-sample, Real-world Study of Sintilimab Plus Bevacizumab/Cetuximab Plus XELOX Regimen for Conversion Therapy in Patients With Advanced Colorectal Cancer
An observational study of Colorectal Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Sintilimab ，bevcizumab/cetuximab，XELOX
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Jun 2023
- Phase
- Observational
- 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
Study population: Patients with initially unresectable advanced colorectal cancer
Who may be able to join
- Patients had to meet all the following conditions to be enrolled in this study:
- Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years; ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
- Baseline blood routine and biochemical parameters of the subjects met the following criteria:
- Blood routine examination standards shall meet: A. WBC \& GT; 4.0 x 10 / L; b. ANC \> 1.5 x 10 / L; C. the ANC acuity 1.5 x 109 / L; D. HB ≥ 80 g/L; E. PLT acuity 100 x 109 / L;
- Biochemical tests shall meet the following standards:
- TBIL 1.5 x ULN or less; B. ALT and AST \& LT; 2.5×ULN, ALT and AST \& LT for patients with liver metastases; 5 x ULN; C. BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min(Cockcroft-Gault formula).
- No history of other tumors； Be willing and able to follow the protocol during the study； Withdraw from the study at any time during the study without any loss; No history of other tumors; Be willing and able to follow the protocol during the study; Written informed consent was provided prior to study screening and was understood by the patient； Expected life ≥ 6 months
Who cannot join
- -
- Patients were not admitted to the study if they met any of the following criteria:
- Cured basal cell carcinoma of the skin and uterus in patients with other malignancies in the past； Cervical carcinoma in situ is excluded;
- Patients with known positive HER-2 test;
- Pregnant or lactating women are in the reproductive period and have not taken effective contraceptive measures, or have fertility requirements during the study period;
- Serious and uncontrolled medical diseases and infections; Chronic bowel disease or short bowel syndrome;
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- Major organ failure, such as compensatory cardiopulmonary, liver and kidney failure; Severe abnormal liver and kidney function metabolism, affecting the normal drug metabolism;
- Patients with investigator-identified propensity for gastrointestinal bleeding and/or abnormal coagulation (INR \& GT; 1.5);
- Active HBV or HCV;
- Patients with peripheral neuropathy NCT-CTCAE ≥ grade 2;
- Patients who were allergic to the drug in the study protocol were not suitable to participate in the clinical study.
- Patients with rheumatic diseases, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, such as ankylosing spondylitis, psoriasis arthritis, gout, pseudogout, etc. Laboratory tests included positive antinuclear antibody, anti-DS-DNA antibody, anti-SM antibody, anti-phospholipid antibody, HLA-B27, rheumatoid factor (RF-igm), anti-cyclic citrulline (CCP) antibody, rheumatoid factor IgG and IgA, antinuclear factor, anti-keratin antibody, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yang Jianjun
Xi’an, Shanxi, 712000
Jianjun Yang, +8613572533693
About this study
Official title: The First Affilcated Hosipital ,the Air Force Medical University
The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Sintilimab ，bevcizumab/cetuximab，XELOX
- 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 ，bevcizumab/cetuximab，XELOXDrug
Patients in this group had previously received the following treatment regimens:
Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W
| Study group | Role | What they receive |
|---|---|---|
| experimental | Patients in this group had previously received the following treatment regimens:
Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W Receives: Drug: Sintilimab ，bevcizumab/cetuximab，XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
Measured: 2-year
Secondary outcomes (3)
ORR
Objective response rate (ORR): Defined as the proportion of patients who achieved a prespecified reduction in tumor volume and maintained a minimum duration, including cases with CR and PR. Objective tumor response was assessed by an independent review committee using the Response Assessment Criteria for solid Tumors (RECIST 1.1 criteria).
Measured: 1-year
DCR
The proportion of all subjects who were randomized and whose best overall response (BOR) was complete response (CR), partial response (PR), and stable disease (SD) according to RECIST1.1 criteria.
Measured: 1-year
OS
It was defined as the time between the start of randomization and the death of the subject from any cause and was calculated in the intention-to-treat population (ITT).
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 posted16 Sep 2022
- Study start1 May 2022
- Primary completion15 Sep 2022
- Study completion30 Jun 2023 (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 Xijing 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544812
- Sponsor's protocol ID
- yangjianjun-2
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 21 Sep 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affilcated Hosipital ,the Air Force Medical University
- ClinicalTrials.gov ID
- NCT05544812
- Acronym / sponsor ID
- yangjianjun-2
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Sep 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.
The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | – | Drug: Sintilimab ，bevcizumab/cetuximab，XELOXPatients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with initially unresectable advanced colorectal cancer
Key inclusion criteria (7 listed)
- Patients had to meet all the following conditions to be enrolled in this study:
- Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years; ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
- Baseline blood routine and biochemical parameters of the subjects met the following criteria:
- Blood routine examination standards shall meet: A. WBC \& GT; 4.0 x 10 / L; b. ANC \> 1.5 x 10 / L; C. the ANC acuity 1.5 x 109 / L; D. HB ≥ 80 g/L; E. PLT acuity 100 x 109 / L;
- Biochemical tests shall meet the following standards:
Key exclusion criteria (12 listed)
- -
- Cured basal cell carcinoma of the skin and uterus in patients with other malignancies in the past； Cervical carcinoma in situ is excluded;
- Patients with known positive HER-2 test;
- Pregnant or lactating women are in the reproductive period and have not taken effective contraceptive measures, or have fertility requirements during the study period;
- Serious and uncontrolled medical diseases and infections; Chronic bowel disease or short bowel syndrome;
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 ，bevcizumab/cetuximab，XELOXPatients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W | Drug | experimental |
Primary outcome
AE
Time frame: 2-year
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
3 secondary outcomes
ORR
Time frame: 1-year
DCR
Time frame: 1-year
OS
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 21 Sep 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?
An observational study of Colorectal Cancer, run by Xijing 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 7 inclusion and 12 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 21 Sep 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.
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 Jianjun Yang (+8613572533693, jianjunyang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (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 21 Sep 2022.