Colorectal CancerPhase 1NCT04761185
Raltitrexed in HIPEC
A Phase 1 study testing Raltitrexed in people with Colorectal Cancer and Raltitrexed, run by Fudan University at 1 site in China.
Trial summary
To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the safety, tolerability, PK, and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Raltitrexed, HIPEC
- What is being tested?
- Raltitrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2020to 30 Jun 2025
- Phase
- Phase 1
- 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
- Ages 18-75 (including 18 and 75), regardless of gender;
- ECOG score ≤1;
- Patients with colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma/mucinous tumor confirmed by histopathology;
- The laboratory test results within 1 week before treatment meet the following conditions:
- White blood cell (WBC) ≥ 4.0×109 /L;Neutrophil count (ANC) ≥ 1.8×109 /L;Platelet (PLT) ≥ 100×109/L;Hemoglobin (Hb) ≥ 80 g/L;Serum total bilirubin (TB) ≤ 1.5×ULN;Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)≤ 2.5×ULN;Blood urea nitrogen (BUN) and blood creatinine (Cr) ≤ 1.5×ULN;
- Patients voluntarily participate in this study, sign written informed consent, have good compliance and are willing to cooperate with the follow-up.
Who cannot join
- Patients with severe complications were considered to be intolerant of postoperative chemotherapy;
- Previous or concurrent malignancy, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;
- Patients with peptic ulcer, gastrointestinal dynamic obstruction, severe active bleeding of the digestive tract, and perforation of the digestive tract;
- Those with a history of allergy to the drug components or metabolites in the program;
- A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- had any heart disease, including :(1) angina;(2) Arrhythmia requiring medical treatment or clinically significant;(3) Myocardial infarction;(4) Heart failure;(5) any other heart disease deemed unfit to participate in this study by the researcher;
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- Female patients during pregnancy and lactation, female patients with fertility and positive test of baseline pregnancy or female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;
- The accompanying diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study;
- A past history of neurological or mental disorders, such as major depression, epilepsy, or dementia, that clearly affect study disclosure or follow-up evaluation;
- Participate in other clinical trials within 30 days of enrollment and receive research drugs and any concomitant treatment containing research drugs;
- Other conditions in which the investigator considers it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy
To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the safety, tolerability, PK, and efficacy.
Read the detailed description
All patients with CRC-PM who underwent CRS at the Department of Colorectal Surgery, Fudan University Shanghai Cancer Center between September 2020 and November 2024 were enrolled as part of the classical 3+3 dose-escalation phase I trial, and within a later expansion cohort. Initially, 3 patients were sequentially evaluated for DLTs at each dose level. The MTD was defined as the highest dose in cohorts where fewer than two of six evaluable patients experienced a DLT. Thereafter, additional patients were enrolled in an expansion cohort to determined the recommended phase II dose (RP2D). The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings, and was further characterized in an expansion cohort at the candidate dose. The RTX-HIPEC protocol used the classical 3+3 dose escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2).
- Conditions
- Colorectal Cancer, Raltitrexed, HIPEC
- Being tested
- Raltitrexed
- Keywords
- Colorectal Cancer, Raltitrexed, HIPEC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
Also called HIPEC
The RTX-HIPEC protocol used classical 3+3 dose-escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| HIPEC using Raltitrexed | Experimental | Not described Receives: Drug: Raltitrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose limiting toxicity.
to determine dose-limiting toxicity
Measured: Within 21 days post-treatment
tolerable dose
to determine maximum tolerable dose
Measured: Up to 21 days post-treatment
the recommended phase II dose (RP2D)
The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings.
Measured: Through study completion, up to 2 years
Secondary outcomes (5)
Maximum concentration (Cmax)
Measured: Up to 48 hours after administration
Time to maximum concentration (Tmax)
Measured: Up to 48 hours after administration
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Measured: Up to 48 hours after administration
Recurrence-free survival (RFS)
Time from RTX-HIPEC date until progression per RECIST v1.1 as assessed by the investigator at local site, or death due to any cause.
Measured: Up to 2 years
Apparent volume of distribution (Vz/F) and clearance (CLz/F)
Measured: Up to 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start18 Sep 2020
- Primary completion28 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Employing a standard 3+3 dose-escalation design, RTX was administered at doses ranging from 3 to 9 mg/m2 during HIPEC.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761185
- Sponsor's protocol ID
- HIPEC-RAL
- Status last verified
- May 2025
- First submitted
- 5 Jan 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT04761185
- Acronym / sponsor ID
- HIPEC-RAL
- Conditions
- Colorectal Cancer, Raltitrexed, HIPEC
- Keywords
- Colorectal Cancer, Raltitrexed, HIPEC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Feb 2021 (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.
To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the safety, tolerability, PK, and efficacy.
Detailed description
All patients with CRC-PM who underwent CRS at the Department of Colorectal Surgery, Fudan University Shanghai Cancer Center between September 2020 and November 2024 were enrolled as part of the classical 3+3 dose-escalation phase I trial, and within a later expansion cohort. Initially, 3 patients were sequentially evaluated for DLTs at each dose level. The MTD was defined as the highest dose in cohorts where fewer than two of six evaluable patients experienced a DLT. Thereafter, additional patients were enrolled in an expansion cohort to determined the recommended phase II dose (RP2D). The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings, and was further characterized in an expansion cohort at the candidate dose. The RTX-HIPEC protocol used the classical 3+3 dose escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Employing a standard 3+3 dose-escalation design, RTX was administered at doses ranging from 3 to 9 mg/m2 during HIPEC.
| Arm | Type | Receives |
|---|---|---|
| HIPEC using Raltitrexed | Experimental | Drug: Raltitrexed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-75 (including 18 and 75), regardless of gender;
- ECOG score ≤1;
- Patients with colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma/mucinous tumor confirmed by histopathology;
- The laboratory test results within 1 week before treatment meet the following conditions:
- White blood cell (WBC) ≥ 4.0×109 /L;Neutrophil count (ANC) ≥ 1.8×109 /L;Platelet (PLT) ≥ 100×109/L;Hemoglobin (Hb) ≥ 80 g/L;Serum total bilirubin (TB) ≤ 1.5×ULN;Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)≤ 2.5×ULN;Blood urea nitrogen (BUN) and blood creatinine (Cr) ≤ 1.5×ULN;
Key exclusion criteria (11 listed)
- Patients with severe complications were considered to be intolerant of postoperative chemotherapy;
- Previous or concurrent malignancy, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;
- Patients with peptic ulcer, gastrointestinal dynamic obstruction, severe active bleeding of the digestive tract, and perforation of the digestive tract;
- Those with a history of allergy to the drug components or metabolites in the program;
- A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
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 |
|---|---|---|
| RaltitrexedAlso: HIPECThe RTX-HIPEC protocol used classical 3+3 dose-escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2) | Drug | HIPEC using Raltitrexed |
Primary outcome
Occurrence of Dose limiting toxicity.
Time frame: Within 21 days post-treatment
to determine dose-limiting toxicity
tolerable dose
Time frame: Up to 21 days post-treatment
to determine maximum tolerable dose
the recommended phase II dose (RP2D)
Time frame: Through study completion, up to 2 years
The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings.
5 secondary outcomes
Maximum concentration (Cmax)
Time frame: Up to 48 hours after administration
Time to maximum concentration (Tmax)
Time frame: Up to 48 hours after administration
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Time frame: Up to 48 hours after administration
Recurrence-free survival (RFS)
Time frame: Up to 2 years
Apparent volume of distribution (Vz/F) and clearance (CLz/F)
Time frame: Up to 48 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raltitrexed in people with Colorectal Cancer and Raltitrexed, run by Fudan 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 6 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: finished, as of the sponsor's last update on 25 Feb 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose limiting toxicity. (time frame: Within 21 days post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.