Colo-rectal CancerPhase 2PRIM-CRC3NCT07904130
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer
A Phase 2 study testing Personalized ultrafractionated stereotactic adaptive radiotherapy, Immunotherapy and Target Therapy in people with Colo-rectal Cancer, run by West China Hospital.
Trial summary
P (Population): Patients with advanced colorectal cancer who have failed at least two prior lines of therapy. I (Intervention): Radiotherapy, immunotherapy, and fruquintinib. C (Comparator): Single-arm study with no control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Personalized ultrafractionated stereotactic adaptive radiotherapy, Immunotherapy and Target Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2026to 1 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Has fully understood the study and voluntarily signed the informed consent form.
- Aged 18-75 years, with no restriction on sex.
- Histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Has experienced disease progression after receiving at least two lines of standard therapy, or has developed intolerable toxicity from standard therapy. Standard therapy is defined as prior treatment with fluoropyrimidine plus leucovorin plus a platinum agent or irinotecan, with or without cetuximab or bevacizumab.
- Has at least one measurable lesion according to RECIST version 1.1.
- ECOG performance status of 0-1.
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- Estimated life expectancy of ≥3 months.
- Willing and able to comply with study procedures and receive treatment, including radiotherapy, immunotherapy, targeted therapy, and follow-up.
- Has adequate organ function, defined as:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet count (PLT) ≥80 × 10⁹/L;
- Hemoglobin (Hb) ≥90 g/L;
- Total bilirubin (TBil) ≤1.5 × the upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 × ULN in patients with liver metastases;
- Serum creatinine ≤1.5 × ULN, or calculated creatinine clearance ≥50 mL/min;
- International normalized ratio (INR) ≤1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN, unless the participant is receiving anticoagulant therapy;
- For participants positive for hepatitis B surface antigen (HBsAg), peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≤1 × 10³ copies/L. Participants with HBsAg positivity and HBV-DNA titer ≥1 × 10³ copies/L may be enrolled if, in the investigator's judgment, their chronic hepatitis B is stable and does not pose an increased risk.
- Women of childbearing potential must agree to use appropriate contraception throughout the study. A serum or urine pregnancy test performed within 24 hours before initiation of chemotherapy must be negative.
- Female participants must not be breastfeeding.
Who cannot join
- Receipt of any investigational drug treatment within 4 weeks before the first administration of study treatment.
- Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional clinical study.
- Receipt of brachytherapy, such as radioactive seed implantation, within 60 days before the first dose.
- Uncontrolled serious illness that, in the investigator's opinion, may impair the participant's ability to receive protocol-specified treatment, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, or active peptic ulcer disease.
- Active, known, or suspected autoimmune disease, including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy. Participants with hypothyroidism requiring hormone replacement therapy and those with skin conditions not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia, may be enrolled.
- Active tuberculosis infection. Participants with active pulmonary tuberculosis within 1 year will be excluded, even if treated. Participants with a history of active pulmonary tuberculosis more than 1 year before enrollment will also be excluded unless they can demonstrate completion of standard anti-tuberculosis therapy.
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- Requirement for long-term systemic corticosteroid therapy at a dose equivalent to >10 mg/day of prednisone, or any other form of immunosuppressive therapy. Participants receiving inhaled or topical corticosteroids may be enrolled.
- Uncontrolled cardiac disease, including New York Heart Association (NYHA) class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; dementia, altered mental status, or any psychiatric disorder that may impair comprehension, provision of informed consent, or completion of study questionnaires.
- History of another malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after curative surgery, or ductal carcinoma in situ of the breast after curative treatment.
- Active gastric or duodenal ulcer, ulcerative colitis, or other gastrointestinal disease; unresected tumors with active bleeding; or any other condition considered by the investigator to pose a risk of gastrointestinal bleeding or perforation. Participants with prior gastrointestinal perforation or gastrointestinal fistula who have not recovered after surgery will be excluded.
- Positive hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody.
- Active infection requiring systemic treatment.
- Contraindication to penpulimab or fruquintinib, including a history of allergy or hypersensitivity to any component of either drug.
- Contraindication to radiotherapy, such as prior adequate-dose radiotherapy to the same site, severe radiation injury to the skin or local tissues/organs, or inability to tolerate re-irradiation.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer: Phase II Study
P (Population): Patients with advanced colorectal cancer who have failed at least two prior lines of therapy.
I (Intervention): Radiotherapy, immunotherapy, and fruquintinib. C (Comparator): Single-arm study with no control group. O (Outcomes): Safety, tolerability, and preliminary efficacy of the combination treatment.
S (Study design): This is a phase II, single-arm clinical study. Radiotherapy will be delivered at 25-50 Gy in 5 fractions, including dose schedules of 40 Gy in 5 fractions and 50 Gy in 5 fractions, combined with fixed-dose immunotherapy and fruquintinib. The study plans to enroll 32 participants.
- Conditions
- Colo-rectal Cancer
- Being tested
- Personalized ultrafractionated stereotactic adaptive radiotherapy, Immunotherapy, Target Therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ultrafractionated stereotactic adaptive radiotherapyRadiation
Radiotherapy will be delivered at 25-50 Gy in 5 fractions, including dose schedules of 40 Gy in 5 fractions and 50 Gy in 5 fractions
ImmunotherapyDrug
Finotonlimab 200 mg administered once every 21 days; each treatment cycle is 21 days
Target TherapyDrug
Fruquintinib 5 mg orally once daily for 14 consecutive days, followed by a 7-day treatment-free interval; each treatment cycle is 21 days.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy and immunotherapy and fruquintinib | Experimental | Not described Receives: Radiation: Personalized ultrafractionated stereotactic adaptive radiotherapy; Drug: Immunotherapy; Drug: Target Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
From the date of first administration of study treatment to the date of first documented tumor progression or death from any cause, whichever occurs first.
Measured: From the date of first administration of study treatment to the date of first documented tumor progression or death from any cause, whichever occurs first，assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904130
- Sponsor's protocol ID
- PRIM-CRC3
- Acronym
- PRIM-CRC3
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer: Phase II Study
- ClinicalTrials.gov ID
- NCT07904130
- Acronym / sponsor ID
- PRIM-CRC3 / PRIM-CRC3
- Conditions
- Colo-rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
P (Population): Patients with advanced colorectal cancer who have failed at least two prior lines of therapy.
I (Intervention): Radiotherapy, immunotherapy, and fruquintinib. C (Comparator): Single-arm study with no control group. O (Outcomes): Safety, tolerability, and preliminary efficacy of the combination treatment.
S (Study design): This is a phase II, single-arm clinical study. Radiotherapy will be delivered at 25-50 Gy in 5 fractions, including dose schedules of 40 Gy in 5 fractions and 50 Gy in 5 fractions, combined with fixed-dose immunotherapy and fruquintinib. The study plans to enroll 32 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy and immunotherapy and fruquintinib | Experimental | Radiation: Personalized ultrafractionated stereotactic adaptive radiotherapy, Drug: Immunotherapy, Drug: Target Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Has fully understood the study and voluntarily signed the informed consent form.
- Aged 18-75 years, with no restriction on sex.
- Histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Has experienced disease progression after receiving at least two lines of standard therapy, or has developed intolerable toxicity from standard therapy. Standard therapy is defined as prior treatment with fluoropyrimidine plus leucovorin plus a platinum agent or irinotecan, with or without cetuximab or bevacizumab.
- Has at least one measurable lesion according to RECIST version 1.1.
Key exclusion criteria (15 listed)
- Receipt of any investigational drug treatment within 4 weeks before the first administration of study treatment.
- Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional clinical study.
- Receipt of brachytherapy, such as radioactive seed implantation, within 60 days before the first dose.
- Uncontrolled serious illness that, in the investigator's opinion, may impair the participant's ability to receive protocol-specified treatment, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, or active peptic ulcer disease.
- Active, known, or suspected autoimmune disease, including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy. Participants with hypothyroidism requiring hormone replacement therapy and those with skin conditions not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia, may be enrolled.
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 |
|---|---|---|
| Personalized ultrafractionated stereotactic adaptive radiotherapyRadiotherapy will be delivered at 25-50 Gy in 5 fractions, including dose schedules of 40 Gy in 5 fractions and 50 Gy in 5 fractions | Radiation | radiotherapy and immunotherapy and fruquintinib |
| ImmunotherapyFinotonlimab 200 mg administered once every 21 days; each treatment cycle is 21 days | Drug | radiotherapy and immunotherapy and fruquintinib |
| Target TherapyFruquintinib 5 mg orally once daily for 14 consecutive days, followed by a 7-day treatment-free interval; each treatment cycle is 21 days. | Drug | radiotherapy and immunotherapy and fruquintinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of first administration of study treatment to the date of first documented tumor progression or death from any cause, whichever occurs first，assessed up to 5 years.
From the date of first administration of study treatment to the date of first documented tumor progression or death from any cause, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalized ultrafractionated stereotactic adaptive radiotherapy, Immunotherapy and Target Therapy in people with Colo-rectal Cancer, run by West China Hospital.
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 19 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shu pei (+86 15881109332, shupei385@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the date of first administration of study treatment to the date of first documented tumor progression or death from any cause, whichever occurs first，assessed up to 5 years.). 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 29 Oct 2026.