ClinicalTrials.gg
Not yet recruitingNCT07904130PRIM-CRC3Updated Oct 29, 2026

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer

A Phase 2 interventional study of Personalized ultrafractionated stereotactic adaptive radiotherapy and Immunotherapy in Colo-rectal Cancer, sponsored by West China Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by West China Hospital · Phase 2, Interventional, and Treatment

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colo-rectal Cancer

Browse trials for

03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 32 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has fully understood the study and voluntarily signed the form.
  • Aged 18-75 years, with no restriction on sex.
  • 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 according to version 1.1.
  • performance status of 0-1.
  • Estimated 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:
  • (ANC) ≥1.5 × 10⁹/L;
  • count (PLT) ≥80 × 10⁹/L;
  • (Hb) ≥90 g/L;
  • Total (TBil) ≤1.5 × the (ULN);
  • (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 × ULN in patients with liver ;
  • Serum creatinine ≤1.5 × ULN, or calculated ≥50 mL/min;
  • (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 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 must agree to use appropriate 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.

Exclusion criteria

Exclusion Criteria:

  • Receipt of any 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 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.
  • Requirement for long-term systemic therapy at a dose equivalent to >10 mg/day of prednisone, or any other form of therapy. Participants receiving inhaled or topical corticosteroids may be enrolled.
  • Uncontrolled cardiac disease, including (NYHA) class II or higher heart failure; unstable angina; myocardial infarction within 1 year; supraventricular or ventricular arrhythmias requiring treatment or intervention; dementia, altered mental status, or any psychiatric disorder that may impair comprehension, provision of , or completion of study questionnaires.
  • History of another 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 virus (HCV) antibody or (HIV) antibody.
  • Active infection requiring systemic treatment.
  • to penpulimab or fruquintinib, including a history of allergy or 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.
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    radiotherapy and immunotherapy and fruquintinib

    Radiation: Personalized ultrafractionated stereotactic adaptive radiotherapy · Drug: Immunotherapy · Drug: Target Therapy

Interventions

  • RadiationPersonalized ultrafractionated stereotactic adaptive radiotherapy

    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

  • DrugImmunotherapy

    Finotonlimab 200 mg administered once every 21 days; each treatment cycle is 21 days

  • DrugTarget Therapy

    Fruquintinib 5 mg orally once daily for 14 consecutive days, followed by a 7-day treatment-free interval; each treatment cycle is 21 days.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 23 months later.

Of 122 non-industry phase 2 interventional studies under Colonic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 23 months is below that.

Counting every sponsor, half of 135 studies reached it within 43 months; a quarter within 30 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2026
First posted
Oct 29, 2026
StartEst.
Oct 9, 2026
Primary completionEst.
Oct 1, 2028
CompletionEst.
Oct 1, 2029
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904130
Responsible party
Wang Xin (Clinical Professor, West China Hospital) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 9, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
Oct 29, 2026

Study contacts

shu pei
Contact
shupei385@gmail.com
+86 15881109332

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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