Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Nanchang University

About this trial

To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have fully understood the study and voluntarily signed the informed consent;

Age ≥18 years old, gender unlimited;

Advanced metastatic colorectal adenocarcinoma confirmed by histopathology;

The patient progressed or was intolerant after receiving at least previous standard therapy containing fluorouracil, oxaliplatin, and irinotecan.

Disqualifiers

Previous treatment with Fruquintinib or other anti-vascular endothelial growth factor receptor (VEGFR) inhibitors such as Apatinib, Regorafenib, and Anlotinib;

Previous treatment with Raltitrexed;

Participated in other drug clinical trials and received at least one drug therapy within four weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks prior to enrollment;

The patient currently has a disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;

Trial design

Design model

Single group

Treatments tested in this trial

  • Fruquintinib

    Drug

    Fruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Fruquintinib combined with Raltitrexed groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

The time from enrollment to disease progression or death

Time frame
From date of randomization until the date of first documented progression or date of death

Secondary outcomes

1

Objective response rate (ORR)

Proportion of patients with complete or partial response

Time frame
through study completion, an average of 1 year
2

Disease control rate (DCR)

Proportion of patients assessed as having a complete response, partial response, or stable disease

Time frame
through study completion, an average of 1 year
3

Overall survival (OS)

Patients were enrolled until their death from any cause

Time frame
Through study completion, an average of 1year
4

Security

Safety was evaluated by adverse reactions

Time frame
Through study completion, an average of 1year

Other outcomes

Sponsors and contacts

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