FruquintinibPhase 2NCT06427005
Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC
A Phase 2 study testing Fruquintinib, S-1 and raltitrexed in people with Fruquintinib and S-1, run by Meng Qiu at 2 sites in China.
Trial summary
Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fruquintinib, S-1, Raltitrexed
- What is being tested?
- Fruquintinib, S-1 and raltitrexed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesChina
- Study dates
- 20 Feb 2023to 30 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, any gender.
- Patients with metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology.
- Expected survival time ≥ 12 weeks.
- ECOG score of 0-2.
- Previously treated for metastatic colorectal cancer with fluoropyrimidine (allowing intravenous and/or oral fluoropyrimidine formulations, excluding DPD enzyme inhibitors), irinotecan, and oxaliplatin chemotherapy, which failed (treatment failure defined as intolerable adverse reactions, disease progression during treatment, or disease progression within 6 months after completing adjuvant chemotherapy); regardless of prior use of targeted drugs such as cetuximab or bevacizumab.
- Patients must have an interval of at least 2 weeks since the last chemotherapy (at least 1 week for oral chemotherapy drugs) or more than 4 weeks since the end of radiotherapy, with the study's observable lesions located outside the radiotherapy target area.
Show all 14Show fewer
- According to RECIST 1.1 criteria, at least one measurable tumor lesion with a maximum diameter ≥ 1 cm as determined by spiral CT scan.
- Laboratory test results within 1 week before enrollment must meet the following criteria:
- Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 75 × 10^9/L;
- White blood cells (WBC) ≥ 3.0 × 10^9/L; Neutrophils (ANC) ≥ 1.5 × 10^9/L;
- Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN);
- Total bilirubin (TBI) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if there is liver metastasis).
- No prior use of raltitrexed or S-1 (or DPD enzyme inhibitors) in the treatment of colorectal cancer.
- Signed informed consent.
Who cannot join
- Patients unable to take oral medications.
- Patients who have previously been treated with small molecule TKI drugs.
- Patients with severe hepatic or renal insufficiency, or a recent history of myocardial infarction (within 3 months).
- Patients with a history of other malignancies within the past five years, except for cured cervical carcinoma in situ and basal cell carcinoma of the skin.
- Patients with a history of inflammatory bowel disease or extensive colonic resection, ≥50% or extensive small bowel resection with chronic diarrhea, or intestinal obstruction.
- Patients with severe uncontrolled internal medical conditions or acute infections (fever > 38°C due to infection).
Show all 11Show fewer
- Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for brain or leptomeningeal metastases > 6 months, with negative imaging results within 4 weeks before study entry, and has stable clinical symptoms related to brain or leptomeningeal metastases at study entry).
- Patients with clinically significant, uncontrolled pleural effusion or ascites despite clinical intervention.
- Pregnant or breastfeeding women, or patients of reproductive potential (males or females not in menopause for less than 1 year) unwilling to use contraception.
- Patients known to be allergic to raltitrexed, S-1, and Fruquintinib or any of their components.
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sichuan University West China Hospital
Chengdu, Sichuan, 610044
Weibing Leng, Ph.D, +8618980921763, lengweibing@wchscu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Meng Qiu, MD, 028-85423203, qiumeng33@hotmail.com
About this study
Official title: Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study
Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.
Read the detailed description
Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and anti-VEGF therapy in the first or second line, including those who had been treated with bevacizumab in two consecutive chemotherapy regimens. Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. The primary endpoint was the ORR, while secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
- Conditions
- Fruquintinib, S-1, Raltitrexed
- Being tested
- Fruquintinib, S-1, raltitrexed
- Keywords
- S-1, Fruquintinib, raltitrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called Elunate
Fruquintinib 5 mg daily for 14 days followed by a 7-day break
S-1Drug
Also called Tegafur,Gimeracil and Oteracil Potassium Capsules
S-1 80-120 mg daily for 14 days, followed by a 7-day break
raltitrexedDrug
Also called thymidylate synthase inhibitor
raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg
| Study group | Role | What they receive |
|---|---|---|
| RSF treatment arm | Experimental | Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. Receives: Drug: Fruquintinib; Drug: S-1; Drug: raltitrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: about a year
Secondary outcomes (3)
DCR
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: about a year
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Measured: about a year
Safety and tolerability
Version 5.0 and AEs leading to dose interruption or discontinuation.
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 Feb 2023
- Primary completion18 Aug 2025 (estimated)
- Study completion30 Apr 2026 (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 FruquintinibStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meng Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Xisike Clinical Oncology Research Foundation
- Responsible party
- Sponsor-investigator, Meng Qiu, West China Hospital
- Investigators
- Meng Qiu, MD., Study director, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427005
- Sponsor's protocol ID
- 2023-71
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leng W, Wen Z, Wang H, Cao P, Liu J, Luo D, Qiu M. Raltitrexed, S-1 and fruquintinib (RSF) in the treatment of refractory metastatic colorectal cancer: study protocol for a multicenter, prospective, single-arm, phase II trial. BMC Cancer. 2025 Feb 28;25(1):376. doi: 10.1186/s12885-025-13654-7.
PubMed 40022044
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study
- ClinicalTrials.gov ID
- NCT06427005
- Acronym / sponsor ID
- 2023-71
- Conditions
- Fruquintinib, S-1, Raltitrexed
- Keywords
- S-1, Fruquintinib, raltitrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Meng QiuUniversity, hospital or other
- Collaborators
- Beijing Xisike Clinical Oncology Research Foundation
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 23 May 2024 (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.
Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.
Detailed description
Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and anti-VEGF therapy in the first or second line, including those who had been treated with bevacizumab in two consecutive chemotherapy regimens. Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. The primary endpoint was the ORR, while secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| RSF treatment arm | Experimental | Drug: Fruquintinib, Drug: S-1, Drug: raltitrexedParticipants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years, any gender.
- Patients with metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology.
- Expected survival time ≥ 12 weeks.
- ECOG score of 0-2.
- Previously treated for metastatic colorectal cancer with fluoropyrimidine (allowing intravenous and/or oral fluoropyrimidine formulations, excluding DPD enzyme inhibitors), irinotecan, and oxaliplatin chemotherapy, which failed (treatment failure defined as intolerable adverse reactions, disease progression during treatment, or disease progression within 6 months after completing adjuvant chemotherapy); regardless of prior use of targeted drugs such as cetuximab or bevacizumab.
Key exclusion criteria (11 listed)
- Patients unable to take oral medications.
- Patients who have previously been treated with small molecule TKI drugs.
- Patients with severe hepatic or renal insufficiency, or a recent history of myocardial infarction (within 3 months).
- Patients with a history of other malignancies within the past five years, except for cured cervical carcinoma in situ and basal cell carcinoma of the skin.
- Patients with a history of inflammatory bowel disease or extensive colonic resection, ≥50% or extensive small bowel resection with chronic diarrhea, or intestinal obstruction.
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 |
|---|---|---|
| FruquintinibAlso: ElunateFruquintinib 5 mg daily for 14 days followed by a 7-day break | Drug | RSF treatment arm |
| S-1Also: Tegafur,Gimeracil and Oteracil Potassium CapsulesS-1 80-120 mg daily for 14 days, followed by a 7-day break | Drug | RSF treatment arm |
| raltitrexedAlso: thymidylate synthase inhibitorraltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg | Drug | RSF treatment arm |
Primary outcome
ORR
Time frame: about a year
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
3 secondary outcomes
DCR
Time frame: about a year
OS
Time frame: about a year
Safety and tolerability
Time frame: about a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 40022044Leng W, Wen Z, Wang H, Cao P, Liu J, Luo D, Qiu M. Raltitrexed, S-1 and fruquintinib (RSF) in the treatment of refractory metastatic colorectal cancer: study protocol for a multicenter, prospective, single-arm, phase II trial. BMC Cancer. 2025 Feb 28;25(1):376. doi: 10.1186/s12885-025-13654-7.
- Individual participant dataSharing planned: No
Related trials for Fruquintinib
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
Not yet recruitingPhase 3
A Phase III Randomized Controlled Trial of Serplulimab Plus Fruquintinib as Adjuvant Therapy for High-Risk Non-Clear Cell Renal Cell Carcinoma
Non-Clear Cell Renal Cell Carcinoma (nccRCC)
Not yet recruitingPhase 2
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer
Colo-rectal Cancer
RecruitingPhase 2
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
Refractory Metastatic Colorectal Cancer
Recruiting
Oral Paclitaxel Plus Fruquintinib Verus Investigator's Choice in Second-Line Advanced Gastric Cancer
Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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.
Meng Qiu, MD. study director
Sichuan University
2 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 Fruquintinib, S-1 and raltitrexed in people with Fruquintinib and S-1, run by Meng Qiu 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 14 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 22 Jan 2025. 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 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 Meng Qiu, MD. (+8618980921776, qiumeng33@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: about a year). 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 NCT06427005, 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 22 Jan 2025.