Advanced Colorectal CancerPhase 2NCT03126071
Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
A Phase 2 study testing Raltitrexed, Irinotecan and Oxaliplatin in people with Advanced Colorectal Cancer, run by Jiangsu Cancer Institute & Hospital at 4 sites in China.
Trial summary
The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Raltitrexed, Irinotecan and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 15 Feb 2017to 15 Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years;
- histological and/or cytological confirmation of ACC;
- disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy;
- at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）
- ECOG performance status 0-1
- life expectancy of at least 3 months
- satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Alkaline phosphatase（ALP）≤3 UNL(For patients with liver metastasis, the ALP must be ≤5.0 UNL);
- written informed consent
Who cannot join
- prior exposure to raltitrexed;
- Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (<=6 months before treatment start),congestive heart failure （New York Heart Association ，NYHA>= grade 3）,stroke or transient ischemic attack
- Accept kidney dialysis treatment now
- chronic enteropathy on unresolved bowel obstruction;
- previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
- the UGT1A1 *28（7/7）*6（A/A） gene type;
- pregnant or lactated women;
- Unsuitable for the study or other chemotherapy determined by investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 3 recruiting
- Recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Liangjun Zhu, +8613905199123, zhulj98@foxmail.com
Yuejiao Zhong, +861370575447, zhongyuejiao@163.com
- Active, not recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226000
- Not yet recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Zhang, M.D.
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Chunrong Zhu, M.D., +8613063870566, zcr050311@163.com
Feng Xiong, +8613270971002, greenlemontea@126.com
About this study
Official title: A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Raltitrexed, Irinotecan, Oxaliplatin, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
IrinotecanDrug
Irinotecan:250mg/m2,iv 90min,d1,q3w.
OxaliplatinDrug
Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
BevacizumabDrug
Also called Avastin
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN) | Experimental | Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w) Receives: Drug: Raltitrexed; Drug: Irinotecan; Drug: Bevacizumab |
| Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN) | Experimental | Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w) Receives: Drug: Raltitrexed; Drug: Oxaliplatin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 6 months
Secondary outcomes (4)
OS
Overall Survival
Measured: 15 months
ORR
Objective Response Rate
Measured: 36 months
DCR
Disease Control Rate
Measured: 36 months
AEs
Percentage of participants experiencing grade 3-5 adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start15 Feb 2017
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Feb 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126071
- Sponsor's protocol ID
- RBACC
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2017
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li S, Li X, Zhu Q, Gao J, Zhu C, Zhu L. Raltitrexed Chemotherapy Regimen Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer: A Prospective Multicenter Phase II Trial. Cancer Control. 2024 Jan-Dec;31:10732748241275012. doi: 10.1177/10732748241275012.
PubMed 39286935
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 Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03126071
- Acronym / sponsor ID
- RBACC
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 24 Apr 2017 (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 raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN) | Experimental | Drug: Raltitrexed, Drug: Irinotecan, Drug: BevacizumabIrinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w) |
| Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN) | Experimental | Drug: Raltitrexed, Drug: Oxaliplatin, Drug: BevacizumabOxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-70 years;
- histological and/or cytological confirmation of ACC;
- disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy;
- at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）
- ECOG performance status 0-1
Key exclusion criteria (8 listed)
- prior exposure to raltitrexed;
- Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (<=6 months before treatment start),congestive heart failure （New York Heart Association ，NYHA>= grade 3）,stroke or transient ischemic attack
- Accept kidney dialysis treatment now
- chronic enteropathy on unresolved bowel obstruction;
- previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
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 |
|---|---|---|
| RaltitrexedRaltitrexed:3mg/m2,iv 15min,d1,q3w. | Drug | Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN), Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN) |
| IrinotecanIrinotecan:250mg/m2,iv 90min,d1,q3w. | Drug | Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN) |
| OxaliplatinOxaliplatin:130mg/m2,iv 120min,d1,q3w. | Drug | Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN) |
| BevacizumabAlso: AvastinBevacizumab:75mg/kg,iv 30min,d1,q3w. | Drug | Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN), Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN) |
Primary outcome
PFS
Time frame: 6 months
Progression Free Survival
4 secondary outcomes
OS
Time frame: 15 months
ORR
Time frame: 36 months
DCR
Time frame: 36 months
AEs
Time frame: 36 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 39286935Li S, Li X, Zhu Q, Gao J, Zhu C, Zhu L. Raltitrexed Chemotherapy Regimen Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer: A Prospective Multicenter Phase II Trial. Cancer Control. 2024 Jan-Dec;31:10732748241275012. doi: 10.1177/10732748241275012.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltitrexed, Irinotecan and Oxaliplatin in people with Advanced Colorectal Cancer, run by Jiangsu Cancer Institute & Hospital at 4 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 8 inclusion and 8 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 4 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 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 Liangjun Zhu (+8613905199123, zhulj98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 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 NCT03126071, 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.