AzTrials
AzTrials

Unresectable Metastatic Colorectal CarcinomaPhase 2NCT04508452

A Phase II Prospective Trial of mXELOXIRI Reintroduction for mCRC

A Phase 2 study testing Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination in people with Unresectable Metastatic Colorectal Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The objective is to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with molecular targeted drug in patients with metastatic colorectal cancer (mCRC) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteChina
Study dates
18 May 2020to 1 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

  • Personal written informed consent is obtained after the study has been fully explained
  • Histologically confirmed colon or rectal adenocarcinoma
  • Excluding appendix cancer and anal canal cancer
  • Clinically unresectable
  • Borderline resectable liver metastases of colorectal cancer considered to have poor-risk disease not deemed to be suitable for upfront resection if they had one or more of the following features assessed by a local multidisciplinary team: more than four metastases, location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (e.g. involvement of both lobes of liver, invasion of intrahepatic vascular structures), extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate postoperative period, and inability to retain adequate vascular inflow and outflow to maintain viable liver function.
  • Age at enrollment is >= 18 and <= 75 years
Show all 11Show fewer
  • Life expectancy of at least 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
  • .Vital organ functions meet the following criteria within 14 days before enrollment.
  • If multiple test results are available in that period, the results closest to enrollment will be used. No blood transfusions or hematopoietic factor administration will be permitted within 2 weeks before the date on which measurements are taken.
  • Absolute neutrophil count (ANC): ≥3,000 /cu.mm ii. Platelet count: ≥10.0 × 104/cu.mm iii. Hemoglobin concentration: ≥8.0 g/dL iv. Prothrombin time (PT), activated partial thromboplastin time(APTT): ≤1.5 times upper limit of normal (ULN) v. Total bilirubin: ≤1.5 times ULN (≤3 times ULN for metastases to liver).Aspartate aminotransferase (AST), Alanine aminotransferase (ALT): ≤2.5 times ULN (≤5 times ULN for metastases to liver).vi. Serum creatinine: ≤1.5 times ULN, or creatinine clearance: ≥30 mL/min

Who cannot join

  • Clinically resectable. Major surgical procedure within 28 days prior to study treatment initiation (such as open chest, laparoscopy, thoracoscopic surgery, laparoscopic surgery), unless only colostomy is performed; open biopsy or suturing for major trauma within 14 days of study treatment initiation; or planned major surgical procedure during the study (open chest, laparoscopy) ("major surgical procedures" does not include central venous (CV) port insertion)
  • Previous adjuvant oxaliplatin-containing chemotherapy
  • 5-Fu-containing chemotherapy within 12 months.
  • .Have received any experimental therapy (such as take part in another clinical study) within 4 weeks before treatment;
  • Receiving immunotherapy, chemotherapy, radiotherapy (except palliative radiotherapy), or hormonotherapy, which are not included in study protocol;
  • Untreated brain metastases, spinal cord compression, or primary brain tumor;
Show all 11Show fewer
  • Pregnant, breastfeeding, positive pregnancy test (women who have menstruated in the last year will be tested), or women who are unwilling to use contraception; men who are unwilling to use contraception during the study
  • Any of the following comorbidities i. Uncontrolled hypertension ii. Uncontrolled diabetes mellitus iii. Uncontrolled diarrhea iv. Peripheral sensory neuropathy (≥Grade 1) v. Active peptic ulcer vi. Unhealed wound (except for suturing associated with implanted port placement) vii. Other clinically significant disease (such as interstitial pneumonia or renal impairment)
  • Subjects with known allergy to the study drugs or to any of its excipients.
  • Any indication of contraindications to chemotherapy;
  • Other active malignancies (synchronous malignancies, and asynchronous malignancies separated by a 5-year disease-free interval) (excluding malignancies that are expected to be completely cured, such as intramucosal carcinoma and carcinoma in situ)

Trial locations and contacts

1 site in 1 country.

Ye Feng, M.D. contact

+8613858191208 ext. 87236858

yefeng-h1@zju.edu.cn

Jiang Weiqin, M.D. contact

+8615068117618

weiqinjiang@zju.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Jiang Weiqin, M.D., +8615068117618, weiqinjiang@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Prospective Trial of mXELOXIRI Reintroduction for the Unresectable Metastatic Colorectal Cancer

The objective is to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with molecular targeted drug in patients with metastatic colorectal cancer (mCRC)

Read the detailed description

It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with bevacizumab as first-line therapy in patients with unresectable mCRC. Eligible patients will receive 12 cycles of mXELOXIRI with bevacizumab and then MDT will be initiated to determine whether to perform a surgery or receive the maintenance therapy until disease progression (PD). At the time of PD, patients will re-introduce XELOXIRI plus bev at the same doses and schedule previously tolerated, for a maximum of 12 cycles.

Being tested
Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab CombinationDrug

    CAP 1,600 mg/sq.m /day (p.o. day1-10) D1-10; Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) D1; Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1; BEV: 5mg/kg (d.i.v.) D1; Administered every 2 weeks.

Study groups in NCT04508452
Study groupRoleWhat they receive
mXELOXIRI+Bev reintroductionExperimentalPatients will receive mXELOXIRI+BEV as first-line therapy (to be repeated every 2 weeks for a maximum of 12 cycles), followed to initiate a MDT to determine whether to perform a surgery or receive maintenance therapy. Maintenance treatment: CAP+BEV. The following CAP+BEV therapy will be repeated in 2-week cycles. At the time of disease progression, patients will be re-introduced XELOXIRI plus bev at the same doses and schedule previously tolerated, for a maximum of 12 cycles. If no progression occurs during XELOXIRI plus bev, patients will receive maintenance CAP+BEV at the same dose used in the last cycle of the induction treatment.
Receives: Drug: Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reintroduction Rate

    The rate of patients who receive reintroduction therapy after the first progression.

    Measured: Up to 18 months

Secondary outcomes (7)

  1. R0 rate

    resection rate

    Measured: Up to 18 months

  2. PFS

    the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 18 months

  3. OS

    the time from randomization to the date of death due to any cause.

    Measured: Up to 18 months

  4. PFS1

    the time from randomization to the first documentation of objective disease progression or death due to any cause before second-line therapy, whichever occurs first.

    Measured: Up to 18 months

  5. ORR1

    percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the first-line induction and the maintenance phases of treatment.

    Measured: Every 8 weeks, up to 18 months after last patient last visit

  6. PFS2

    from the beginning of the second-line treatment to the documentation of objective disease progression or death due to any cause, whichever occurs first

    Measured: up to 18 months after last patient last visit

  7. ORR2

    percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the second-line induction and the maintenance phases of treatment.

    Measured: Every 8 weeks, up to 18 months after last patient last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start18 May 2020
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

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
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508452
Sponsor's protocol ID
TRICAP-2
Status last verified
Jan 2021
First submitted
9 Aug 2020
Last updated
2 Feb 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination in people with Unresectable Metastatic Colorectal Carcinoma, run by First Affiliated Hospital of Zhejiang University 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 11 inclusion and 11 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 2 Feb 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 Ye Feng, M.D. (+8613858191208 ext. 87236858, yefeng-h1@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reintroduction Rate (time frame: Up to 18 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 NCT04508452.

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 2 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in