Metastatic CancerPhase 1/2NCT04380103
A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal Cancer
A Phase 1/2 study testing XELOXIRI/Bevacizumab in people with Metastatic Cancer and Colorectal Cancer, run by Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
The phase I/II study was designed to evaluate if the regimen of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab is a superior first-line option for patients with metastatic colorectal cancer(mCRC) in terms of safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Cancer, Colorectal Cancer, Colorectal Adenocarcinoma
- What is being tested?
- XELOXIRI/Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesChina
- Study dates
- 26 Apr 2020to Sep 2022
- Phase
- Phase 1/2
- 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
- Patients with histologically confirmed metastatic colorectal adenocarcinoma;
- Age 18-80 years old;
- Eastern Cooperation Oncology Group (ECOG) performance score(<2);
- At least one measurable lesion for disease assessment according to RECIST version 1.1;
- Able to take oral medications;
- Previous fluoropyrimidine-based adjuvant or neoadjuvant chemotherapy was allowed only when it ended ≥ 6 months before study enrollment;
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- No previous therapy for mCRC;
- Adequate organ functions as assessed by the following laboratory requirements: Leukocytes≥3.0x109/L, absolute neutrophil count≥1.5x109/L, platelet count≥100x109/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤3x ULN; serum creatinine≤1.5x ULN; calculated creatinine clearance or 24 hour creatinine clearance ≥60ml/min.
- An expected survival of at least 3 months;
- Willingly provide written informed consent to study procedures.
Who cannot join
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- With a history of extensive enterotomy or pelvic radiation therapy; Suffering from grade 2 or higher symptomatic peripheral neuropathy according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
- Uncontrolled central nervous system metastasis, disseminated intravascular coagulation or active infection;
- With concurrent cancer distinct from colorectal adenocarcinoma except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Undergone a major operation, open biopsy or major traumatic injury within 28 days before study enrollment or have potential to receive major operation during the trial;
- Received central venous access device within 2 days before study enrollment;
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- Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2 or uncontrolled hypertension.
- With positive urine protein and 24-hour urinary protein content>1g;
- Have a tendency of bleeding or clotting;
- With nasty open wounds, ulcers or fractures;
- Current or recent treatment of anticoagulants, antiplatelet agent or nonsteroidal anti-inflammatory drugs, while aspirin of daily dose less than 325mg is allowed.
- With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results;
- Pregnancy or lactation at the time of study entry;
- With fertility but refuse to contraception.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
Beijing
Lin Yang, M.D, 13681015148 ext. 13681015148, lyang69@sina.com
Lin Yang, M.D
- Recruiting
National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing
Lin Yang, M.D, 13681015148 ext. 13681015148, lyang69@sina.com
Lin Yang, M.D
About this study
Official title: A Phase I/II Study of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab as a First-line Therapy for Patients With Metastatic Colorectal Cancer
The phase I/II study was designed to evaluate if the regimen of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab is a superior first-line option for patients with metastatic colorectal cancer(mCRC) in terms of safety and efficacy.
Read the detailed description
Recent studies have shown that the triplet-drug regimen FOLFOXIRI (irinotecan/oxaliplatin/fluorouracil) can further improves survival benefit for patients with metastatic colorectal cancer(mCRC) compared to standard two-drug regimens in first-line therapy, especially when combined with bevacizumab. However, the increased toxicities of FOLFOXIRI limited its usage. Capecitabine demonstrates a superior efficacy and safety than fluorouracil, so we designed this trial to evaluate if the XELOXIRI plus bevacizumab can be a better alternative to FOLFOXIRI plus bevacizumab. The phase I study is to determine the safety and the recommended phase II dose (RP2D) of XELOXIRI plus Bevacizumab. In the phase II study, we aim to determine the efficacy of the regimen as first-line therapy for mCRC and explore potential molecular biomarkers (genomes, circulating tumor cell) for toxicity forecasting or efficacy monitoring.
- Being tested
- XELOXIRI/Bevacizumab
- Keywords
- metastatic colorectal cancer, metastatic colorectal adenocarcinoma, XELOXIRI, bevacizumab
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELOXIRI/BevacizumabDrug
Also called Irinotecan, Oxaliplatin, Capecitabine, Bevacizumab
bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7 repeated every 2 week for 12 cycles, after 12 cycles, bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy repeated every 2 week
| Study group | Role | What they receive |
|---|---|---|
| XELOXIRI/Bevacizumab | Experimental | drugs: Irinotecan, Oxaliplatin, Capecitabine, Bevacizumab bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7, administered every 2 week for 12 cycles, after 12 cycles, administer bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy. Receives: Drug: XELOXIRI/Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limited toxicity (DLT)
dose limited toxicities are evaluated in the phase I study according to CTCAE v5.0 and reviewed through the phase I study completion
Measured: up to 1 year
maximum tolerated dose (MTD)
MTD is determined according to the DLT in the phase I study
Measured: up to 1 year
recommended phase 2 dose (RP2D)
RP2D is determined according to DLT and MTD in the phase 1 study
Measured: up to 1 year
objective response rate (ORR)
ORR is defined as the proportion of patients achieving complete response or partial response
Measured: up to 2 years
Secondary outcomes (7)
Adverse events (AEs)
Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0
Measured: though study completion, an average of 2 years
progression-free survival (PFS)
PFS is defined as the time from randomization to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause
Measured: though study completion, an average of 2 years
overall survival (OS)
OS is defined as the time from randomized to death from any cause or to last contact
Measured: up to 5 years
disease control rate (DCR)
DCR is defined as the proportion of patients achieving complete response, partial response or having stable disease
Measured: up to 2 years
duration of response (DOR)
DOR is defined as the length from the first response occured to disease progression
Measured: though study completion, an average of 2 years
time to response (TTR)
TTR is defined as the length from randomization to the first response occured.
Measured: up to 2 years
the surgical resection rate of patients with liver-only metastases
the percentage of patients with liver-only metastases undergoing surgical resections during the trial therapy
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start26 Apr 2020
- Primary completionDec 2020 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Chinese Academy of Medical Sciences
- Investigators
- Lin Yang, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380103
- Sponsor's protocol ID
- NCC2271
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 8 May 2020
- 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab as a First-line Therapy for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04380103
- Acronym / sponsor ID
- NCC2271
- Keywords
- metastatic colorectal cancer, metastatic colorectal adenocarcinoma, XELOXIRI, bevacizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 26 Apr 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 May 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 phase I/II study was designed to evaluate if the regimen of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab is a superior first-line option for patients with metastatic colorectal cancer(mCRC) in terms of safety and efficacy.
Detailed description
Recent studies have shown that the triplet-drug regimen FOLFOXIRI (irinotecan/oxaliplatin/fluorouracil) can further improves survival benefit for patients with metastatic colorectal cancer(mCRC) compared to standard two-drug regimens in first-line therapy, especially when combined with bevacizumab. However, the increased toxicities of FOLFOXIRI limited its usage. Capecitabine demonstrates a superior efficacy and safety than fluorouracil, so we designed this trial to evaluate if the XELOXIRI plus bevacizumab can be a better alternative to FOLFOXIRI plus bevacizumab. The phase I study is to determine the safety and the recommended phase II dose (RP2D) of XELOXIRI plus Bevacizumab. In the phase II study, we aim to determine the efficacy of the regimen as first-line therapy for mCRC and explore potential molecular biomarkers (genomes, circulating tumor cell) for toxicity forecasting or efficacy monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XELOXIRI/Bevacizumab | Experimental | Drug: XELOXIRI/Bevacizumabdrugs: Irinotecan, Oxaliplatin, Capecitabine, Bevacizumab bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7, administered every 2 week for 12 cycles, after 12 cycles, administer bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed metastatic colorectal adenocarcinoma;
- Age 18-80 years old;
- Eastern Cooperation Oncology Group (ECOG) performance score(<2);
- At least one measurable lesion for disease assessment according to RECIST version 1.1;
- Able to take oral medications;
Key exclusion criteria (14 listed)
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- With a history of extensive enterotomy or pelvic radiation therapy; Suffering from grade 2 or higher symptomatic peripheral neuropathy according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
- Uncontrolled central nervous system metastasis, disseminated intravascular coagulation or active infection;
- With concurrent cancer distinct from colorectal adenocarcinoma except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Undergone a major operation, open biopsy or major traumatic injury within 28 days before study enrollment or have potential to receive major operation during the trial;
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 |
|---|---|---|
| XELOXIRI/BevacizumabAlso: Irinotecan, Oxaliplatin, Capecitabine, Bevacizumabbevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7 repeated every 2 week for 12 cycles, after 12 cycles, bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy repeated every 2 week | Drug | XELOXIRI/Bevacizumab |
Primary outcome
dose-limited toxicity (DLT)
Time frame: up to 1 year
dose limited toxicities are evaluated in the phase I study according to CTCAE v5.0 and reviewed through the phase I study completion
maximum tolerated dose (MTD)
Time frame: up to 1 year
MTD is determined according to the DLT in the phase I study
recommended phase 2 dose (RP2D)
Time frame: up to 1 year
RP2D is determined according to DLT and MTD in the phase 1 study
objective response rate (ORR)
Time frame: up to 2 years
ORR is defined as the proportion of patients achieving complete response or partial response
7 secondary outcomes
Adverse events (AEs)
Time frame: though study completion, an average of 2 years
progression-free survival (PFS)
Time frame: though study completion, an average of 2 years
overall survival (OS)
Time frame: up to 5 years
disease control rate (DCR)
Time frame: up to 2 years
duration of response (DOR)
Time frame: though study completion, an average of 2 years
time to response (TTR)
Time frame: up to 2 years
the surgical resection rate of patients with liver-only metastases
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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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.
Lin Yang principal investigator
Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XELOXIRI/Bevacizumab in people with Metastatic Cancer and Colorectal Cancer, run by Chinese Academy of Medical Sciences at 2 sites 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 10 inclusion and 14 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 M.D (13681015148 ext. 13681015148, lyang69@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limited toxicity (DLT) (time frame: up to 1 year). The study lists 4 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 8 May 2020.