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Unresectable Metastatic Colorectal CancerPhase 2TRICAPNCT04160416

mXELOXIRI Combined With Molecular Targeted Drug in mCRC

A Phase 2 study testing Capecitabine-Oxaliplatin-Irinotecan Combination in people with Unresectable Metastatic Colorectal Cancer, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The objective is to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy 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 Combination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Jul 2019to 1 Jan 2022
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 >= 20 and <= 75 years
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  • 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).
  • Serum creatinine: ≤1.5 times ULN, or creatinine clearance: ≥30 mL/min

Who cannot join

  • Previous chemotherapy for other malignancies
  • 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)
  • 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;
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  • 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)
  • Patients are receiving CYP3A4 strong inducer, including but not limited to aminoglutethimide, bexarotene, bosentan, carbamazepine, dexamethasone, efavirenz, fosphenytoin, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, diphenylhydantoin, primidone, rifabutin, rifampicin, rifapentine, hypericum perforatum;
  • The investigator judges that patients can not finish the clinical study due to medical, social, or psychological reasons, or can not sign a valid informed consent;
  • Patients with parenchymal organ transplantation who need to receive immunosuppressive therapy;
  • Evidence of HIV infection.

Trial locations and contacts

1 site in 1 country.

Jiang F Weiqin, M.D contact

+86 15068117618 ext. 87236858

1312028@zju.edu.cn

He F Yinjun, Master contact

+86 18867139782 ext. 87236858

3150103327@zju.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Jiang Weiqin, M.D, +86 15068117618, 1312028@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: mXELOXIRI Combined With Molecular Targeted Drug as First-line Therapy in Patients With Initially Unresectable Metastatic Colorectal Cancer: A Phase II, Single-arm, Prospective Clinical Study

The objective is to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy 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 modified XELOXIRI combined with molecular targeted drug as first-line therapy in patients with unresectable mCRC. Eligible patients will receive 8 cycles of mXELOXIRI with cetuximab or bevacizumab and then the maintenance therapy until disease progression (PD) or unacceptable toxicity, whichever occurs first. Study evaluation time is defined as up to 16 weeks after the first dosing of the last patient.

Being tested
Capecitabine-Oxaliplatin-Irinotecan Combination

What participants receive

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

  • Capecitabine-Oxaliplatin-Irinotecan 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; CET: 500 mg/sq.m (d.i.v.) D1; Administered every 2 weeks.

Study groups in NCT04160416
Study groupRoleWhat they receive
mXELOXIRIExperimentalInduction therapy is followed by the maintenance therapy. Induction treatment: XELOXIRI+CET/BEV Administered for 6 cycles (a maximum of 8 cycles).Bevacizumab (BEV): 5mg/kg (d.i.v.); Cetuximab 500mg/sq.m (d.i.v.)；Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) Irinotecan (IRI):135 mg/sq.m (d.i.v.) CAP 1,600 mg/sq.m /day (p.o. day1-10) Administered every 2 weeks. Maintenance treatment: CAP+CET/BEV. The following CAP+BEV/CET therapy will be repeated in 2-week cycles.
Receives: Drug: Capecitabine-Oxaliplatin-Irinotecan Combination

What is being measured

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

  1. ORR

    Overall response rate

    Measured: Up to 36 months

  2. PFS

    Progression-free survival

    Measured: Up to 18 months

  3. R0 rate

    resection rate

    Measured: Up to 18 months

  4. OS

    Overall Survival

    Measured: Up to 36 months

  5. Incidence of adverse events

    Adverse events were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. All adverse events was collected in duration from starting treatment to whichever shorter "after 30 days from withdrawal treatment" or "later treatment

    Measured: Up to 36 months

Timeline

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

  1. First posted13 Nov 2019
  2. Study start1 Jul 2019
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 Jan 2022 (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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04160416
Sponsor's protocol ID
TRICAP
Acronym
TRICAP
Status last verified
Nov 2019
First submitted
9 Nov 2019
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
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 Combination in people with Unresectable Metastatic Colorectal Cancer, 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 12 inclusion and 15 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 19 Nov 2019. 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 Jiang F Weiqin, M.D (+86 15068117618 ext. 87236858, 1312028@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 36 months). The study lists 5 primary outcomes in all. 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 NCT04160416.

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 19 Nov 2019.

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