Advanced Colorectal CancerPhase 2NCT04324476
A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer
A Phase 2 study testing Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine in people with Advanced Colorectal Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to Jun 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
- 18-75 years old;
- Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed;
- ECOG score ≤ 2, estimated survival time ≥ 3 months;
- Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L, platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value;
- At least one lesion can be measured by CT or MRI;
- No other history of malignant tumor;
- Those who are fertile but willing to take contraceptive measures;
- Sign the written informed consent.
Who cannot join
- Patients with allergic, hypersensitive constitution and autoimmune diseases;
- There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions;
- Pregnant or lactated women;
- Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms;
- Major organ failure;
- Affecting drug administration, absorption, distribution, metabolism, excretion, etc. the patient has uncontrollable epileptic attack, central nervous system disorder or loss of self-knowledge due to mental disease, physiological or pathological malnutrition, chronic diarrhea, and cachexia;
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- Patients with complete or incomplete ileus；
- Patients with serious heart disease or history, including documented history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension;
- Severe uncontrollable infection;
- Alcohol and /or drug abuse or poor compliance of the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Zhu Liangjun, +8613905199123, zhulj98@foxmail.com
Li Sheng, +8613770768636, lihsh198@163.com
About this study
Official title: A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer
The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.
Read the detailed description
XELOX is a commonly used chemotherapy regimen, and XELIRI has also been widely used in the second-line treatment. XELOX and XELIRI adopt the three-week regimen, and the single dose of oxaliplatin and irinotecan is large, which has a great impact on the gastrointestinal toxicity and blood toxicity of patients. Therefore, there is no lack of a two-week improved regimen with increased frequency and reduced single dose applied in clinical, so that it has good safety, exact efficacy and increase the drug delivery density. Based on the above, we should not only consider the efficiency of the three drugs, but also control the toxic reaction. The objective is to evaluate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab、Oxaliplatin、Irinotecan、CapecitabineDrug
Drug: Bevacizumab 5mg/kg, iv, 30min, d1, 2w; Drug: Oxaliplatin 85mg/㎡, iv, 120min, d1, 4W; Drug: Irinotecan 150mg/㎡, iv, 90min, d15, 4w; Drug: Capecitabine 1000mg/㎡, bid, d2-8, 2w.
| Study group | Role | What they receive |
|---|---|---|
| Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI | Experimental | Induction chemotherapy:
Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI:
Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w.
Maintenance chemotherapy:
Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w. Receives: Drug: Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival 1 (PFS 1)
Measured: 28 months
Secondary outcomes (4)
Progression Free Survival 2 (PFS 2)
Measured: 28 months
Objective Response Rate (ORR)
Measured: 28 months
Overall Survival (OS)
Measured: 28 months
The occurrence of adverse reactions (AEs)
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Sep 2019
- Primary completionJul 2022 (estimated)
- Study completionJun 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 Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangjun Zhu M.M., Jiangsu Cancer Institute & Hospital
- Investigators
- Zhu Liangjun, Study chair, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324476
- Sponsor's protocol ID
- JS-GI1902
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li S, Li X, Xu H, Huang J, Zhu J, Peng Y, Bao J, Zhu L. Alternating modified CAPOX/CAPIRI plus bevacizumab in untreated unresectable metastatic colorectal cancer: a phase 2 trial. Signal Transduct Target Ther. 2024 Dec 11;9(1):346. doi: 10.1038/s41392-024-02048-z.
PubMed 39658608
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04324476
- Acronym / sponsor ID
- JS-GI1902
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 27 Mar 2020 (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 objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.
Detailed description
XELOX is a commonly used chemotherapy regimen, and XELIRI has also been widely used in the second-line treatment. XELOX and XELIRI adopt the three-week regimen, and the single dose of oxaliplatin and irinotecan is large, which has a great impact on the gastrointestinal toxicity and blood toxicity of patients. Therefore, there is no lack of a two-week improved regimen with increased frequency and reduced single dose applied in clinical, so that it has good safety, exact efficacy and increase the drug delivery density. Based on the above, we should not only consider the efficiency of the three drugs, but also control the toxic reaction. The objective is to evaluate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI | Experimental | Drug: Bevacizumab、Oxaliplatin、Irinotecan、CapecitabineInduction chemotherapy: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI: Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w. Maintenance chemotherapy: Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old;
- Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed;
- ECOG score ≤ 2, estimated survival time ≥ 3 months;
- Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L, platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value;
- At least one lesion can be measured by CT or MRI;
Key exclusion criteria (10 listed)
- Patients with allergic, hypersensitive constitution and autoimmune diseases;
- There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions;
- Pregnant or lactated women;
- Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms;
- Major organ failure;
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 |
|---|---|---|
| Bevacizumab、Oxaliplatin、Irinotecan、CapecitabineDrug: Bevacizumab 5mg/kg, iv, 30min, d1, 2w; Drug: Oxaliplatin 85mg/㎡, iv, 120min, d1, 4W; Drug: Irinotecan 150mg/㎡, iv, 90min, d15, 4w; Drug: Capecitabine 1000mg/㎡, bid, d2-8, 2w. | Drug | Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI |
Primary outcome
Progression Free Survival 1 (PFS 1)
Time frame: 28 months
4 secondary outcomes
Progression Free Survival 2 (PFS 2)
Time frame: 28 months
Objective Response Rate (ORR)
Time frame: 28 months
Overall Survival (OS)
Time frame: 28 months
The occurrence of adverse reactions (AEs)
Time frame: 28 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 39658608Li S, Li X, Xu H, Huang J, Zhu J, Peng Y, Bao J, Zhu L. Alternating modified CAPOX/CAPIRI plus bevacizumab in untreated unresectable metastatic colorectal cancer: a phase 2 trial. Signal Transduct Target Ther. 2024 Dec 11;9(1):346. doi: 10.1038/s41392-024-02048-z.
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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.
Zhu Liangjun study chair
Jiangsu Cancer Institute & Hospital
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 Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine in people with Advanced Colorectal Cancer, run by Jiangsu Cancer Institute & 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 8 inclusion and 10 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 Aug 2021. 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 Zhu Liangjun (+8613770575447, zhulj98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival 1 (PFS 1) (time frame: 28 months). 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 NCT04324476, 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 30 Aug 2021.