ClinicalTrials.gg
Not yet recruitingNCT07243938Updated Nov 24, 2025

Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

A Phase 2 interventional study of short-course radiotherapy and Zanidatamab in Locally Advanced Rectal Cancer (LARC), Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma and Metastatic Colorectal Cancer (mCRC), sponsored by Tao Zhang. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Tao Zhang · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.

Read the detailed description

This study is a prospective, multi-cohort clinical trial designed to explore the preliminary efficacy and safety of zanidatamab combined with tislelizumab and chemoradiotherapy in patients with HER2-positive locally advanced or metastatic gastrointestinal tumors. The study comprises three cohorts: ①Locally Advanced Rectal Cancer Cohort: Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab and chemoradiotherapy for neoadjuvant and organ-preserving therapy in patients with HER2-positive locally advanced rectal cancer, as measured by investigator-assessed complete response rate (CR rate).②Locally Advanced Gastric/Gastroesophageal Junction Cancer Cohort:Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab and chemotherapy for neoadjuvant treatment in patients with HER2-positive locally advanced gastric/gastroesophageal junction cancer based on investigator-assessed pathological complete response rate (pCR rate).③Advanced-line colorectal cancer cohort: Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab in patients with HER2-positive advanced-line colorectal cancer based on investigator-assessed progression-free survival (PFS).

02

Conditions studied

  • Locally Advanced Rectal Cancer (LARC)
  • Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
  • Metastatic Colorectal Cancer (mCRC)
  • Neoadjuvant Therapy
03

In context

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

This study's planned enrollment of 70 is close to the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Tao Zhang is the lead sponsor of 17 studies on the registry; 10 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

  • Clinical diagnosis of gastric cancer and colorectal cancer
  • Aged 18 to 75 years:
  • Able to sign a written form and understand and comply with the requirements and evaluation schedule of this study
  • (ECOG) performance status ≤ 1
  • -Positive: Immunohistochemistry (IHC) 3+ or IHC 2+ with FISH+ or NGS testing for high expression
  • Locally advanced rectal cancer cohort:

    1. Histopathologically confirmed rectal adenocarcinoma
    2. Tumor tissue confirmed by immunohistochemistry (IHC) as pMMR (high expression of MLH1, MSH2, MSH6, and PMS2 proteins), or confirmed by PCR or NGS as MSI-L or MSS
    3. Tumor lower margin ≤10 cm from anal margin confirmed by colonoscopy, digital rectal examination, or MRI
    4. Clinical stage cT3-4N0M0/cTanyN+M0 (TNM staging per UICC/AJCC 8th edition; T and N stages assessed by MRI)
    5. Patients with one or more risk factors identified by MRI assessment: T4, tumor involvement of the mesorectal fascia (high MRF expression), extramural vascular invasion (high EMVI expression), ≥4 regional lymph node (cN2), high lateral lymph node expression, or tumor margin ≤5 cm from the anal verge with strong organ preservation intent
    6. No prior antitumor therapy for rectal cancer (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine/formulated Chinese medicine treatment)
  • Locally Advanced Gastric/Gastroesophageal Junction Cancer Cohort:

    1. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
    2. Clinical stage III-IVa (i.e., TNM staging T3\~4aN+M0 or T4bNanyM0, refer to UICC/AJCC 8th edition)
    3. No prior antitumor therapy for gastric or gastroesophageal junction adenocarcinoma (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine/Chinese patent medicine treatment)
  • Advanced colorectal cancer cohort:

    1. Histopathologically confirmed advanced colorectal cancer
    2. Previous systemic anticancer therapy for metastatic colorectal cancer with documented failure, including fluoropyrimidine, oxaliplatin, irinotecan, cetuximab, or bevacizumab (excluding ). Prior anti-HER2 therapy permitted
    3. At least one defined according to 1.1
    4. Expected survival > 3 months
  • Good organ function within ≤7 days prior to first study drug administration, as demonstrated by the following laboratory values:

    1. No blood or transfusions or growth factor support therapy within ≤14 days prior to blood sample collection during the screening period, and must meet:
    2. ≥ 1.5 x 10⁹/L
    3. Platelet count ≥ 100 x 10⁹/L
    4. ≥ 90 g/L
    5. Serum creatinine ≤ 1.5 times the (ULN)
    6. and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)
    7. Serum total ≤ 1.5 times ULN (≤ 3 times ULN for patients with liver metastases)
    8. (INR) ≤ 1.5 or Prothrombin Time ≤ 1.5 times ULN
    9. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN
    10. Serum albumin ≥ 30 g/L
  • Female subjects of must have a negative serum pregnancy test within 72 hours prior to the first dose and must be willing to use highly effective during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 120 days after the last dose.

Exclusion criteria

Exclusion Criteria:

Subjects with any of the following conditions are ineligible for inclusion in this study:

  • History of or concurrent other , except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ, provided complete remission was achieved at least 5 years prior to screening and no additional treatment is required or anticipated during the study period.
  • Any of the following cardiovascular criteria:

    1. Cardiac chest pain occurring ≤28 days prior to the first study drug administration, defined as moderate pain limiting daily activities or exercise
    2. Symptomatic pulmonary embolism within ≤28 days prior to the first dose of study drug
    3. History of any acute myocardial infarction within ≤6 months prior to the first dose of study drug
    4. History of any (NYHA) Class III or IV heart failure within ≤6 months prior to the first dose of study drug
    5. Any ventricular arrhythmia event of severity ≥ Grade 2 within ≤ 6 months prior to the first dose of the study drug
    6. History of any cerebrovascular accident within ≤6 months prior to the first dose of the study drug
    7. interval (QTc) (corrected using Fridericia's formula) ≥ 470 msec in females or ≥ 450 msec in males

    i) Note: If any patient's initial shows a QTc interval > 450 msec (male) or > 470 msec (female), a follow-up ECG will be performed to verify the result h) (LVEF) ≤50% as assessed by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO). Follow-up assessment must use the same modality as the baseline assessment

  • Any syncope or seizure occurring ≤28 days prior to the first study drug administration.
  • Active disease requiring systemic treatment within the past 2 years.
  • Known history of (HIV) infection
  • Untreated chronic or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500 IU/mL) or active carriers with detectable HCV RNA; Note: Inactive hepatitis B surface antigen (HBsAg) carriers and treated, stable hepatitis B patients (HBV DNA \< 500 IU/mL) are eligible for enrollment
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary conditions, including pulmonary fibrosis, acute pulmonary disease, etc.
  • Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first study drug dose. Note: Antiviral therapy is permitted for patients with viral hepatitis.
  • Any condition requiring systemic treatment with (prednisone or equivalent >10 mg/day) or other agents within ≤14 days prior to the first dose of study drug
  • to any component of tislelizumab, zanidatamab,capecitabine, S-1, oxaliplatin, or any component of the container
  • Any major surgery requiring general anesthesia within ≤28 days prior to the first dose of study drug
  • Bleeding, thrombotic disorders, or use of anticoagulants (e.g., warfarin) or similar agents requiring therapeutic monitoring within 6 months prior to the first dose of study drug
  • History of stem cell transplantation or organ transplantation
  • administration within ≤28 days prior to the first study drug dose. Note: Seasonal influenza vaccines, broadly classified as inactivated vaccines, are permitted. Inactivated COVID-19 vaccines are permitted. mRNA COVID-19 vaccines are not permitted. Intranasal influenza vaccines are live vaccines and are not permitted.
  • Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the participant is in the follow-up period of an interventional study
  • Inability to swallow tablets or diseases significantly affecting gastrointestinal function
  • Pregnant or lactating women
  • Other conditions deemed ineligible by the investigator.
  • Locally Advanced Rectal Cancer Cohort:

    1. Previous treatment for rectal cancer, or clinical or imaging evidence of existing or potential distant
    2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation with bleeding, prior abdominal abscess, or recent (within 3 months) occurrence of gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding
    3. Assessed by the investigator as initially unresectable or unable to tolerate surgery
    4. Patient assessed by the investigator as having factors rendering them unsuitable for radiotherapy
    5. The patient has ≥2 concurrent colorectal cancer lesions
    6. Patient has for MRI examination
  • Locally Advanced Gastric/Gastroesophageal Junction Cancer Cohort:

    1. Previous treatment for gastric/gastroesophageal junction cancer, or clinical/imaging evidence of existing or potential distant metastasis
    2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation, or bleeding; prior abdominal abscess; or recent (within 3 months) gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding
    3. Initial inoperability as assessed by the investigator, or inability of the patient to tolerate surgery
  • Advanced colorectal cancer cohort:

    1. Patients with any prior histopathological or hematological ctDNA testing demonstrating mismatch repair gene deficiency (dMMR) or microsatellite instability (MSI-H)
    2. Presence of active or uncontrolled . Patients with previously treated brain metastases may be eligible if imaging shows stability, confirmed by repeat imaging demonstrating no progression for at least 4 weeks (Note: repeat imaging must occur during the study screening period).
Terms in these criteria, in plain language(32)

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.

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.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

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

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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.

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.

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.

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.

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.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Locally Advanced Rectal Cancer Cohort

    All patients receive short-course radiotherapy (SCRT) (dose: 25 Gy, 5 Gy × 5 fractions), followed sequentially by 6 cycles of CAPOX chemotherapy combined with zanidatamab and tislelizumab. Following completion of the above treatment, patients underwent clinical complete response (cCR) assessment. Those assessed as cCR were placed on watchful waiting, while those assessed as non-cCR underwent Total Mesorectal Excision (TME). Postoperatively, investigators selected treatment regimens based on patient status.

    Radiation: short-course radiotherapy · Drug: Zanidatamab · Drug: Tisleizumab(BGB-A317) · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery

  • Experimental
    Locally Advanced Gastric/Gastroesophageal Junction Cancer Cohort

    Subjects receive 3 cycles of zanidatamab and tislelizumab combined with SOX therapy. Following treatment completion, undergo D2 gastrectomy. Postoperatively, continue with 5 cycles of zanidatamab and tislelizumab combined with SOX adjuvant therapy.

    Drug: Zanidatamab · Drug: Tisleizumab(BGB-A317) · Drug: Oxaliplatin · Drug: S-1 · Procedure: D2

  • Experimental
    Advanced colorectal cancer cohort

    Subjects receive zanidatamab until disease progression or intolerable toxicity. Under specific circumstances, subjects may continue treatment after radiographic progression if the investigator assesses ongoing benefit; this decision will be made at the investigator's discretion.

    Drug: Zanidatamab

Interventions

  • Radiationshort-course radiotherapy

    25Gy, 5Gy×5

  • 1800mg(\<70kg)/2400mg(≥70kg), IV,D1,Q3W

  • 200 mg,IV,D1,Q3W

  • 1000mg/m2/time,BID,PO,D1-14, Q3W

  • 130 mg/m2/次,IV,D1, Q3W

  • ProcedureTME surgery

    The surgery was performed 4 - 6 weeks after the end of neoadjuvant therapy in patients who assessed as non-cCR.

  • DrugS-1

    Drug pages: Tegafur · Gimeracil · Oxonic Acid

    40\~60mg bid,po, d1\~14,Q3W (S-1:BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid)

  • ProcedureD2

    Radical gastrectomy with D2 lymph node dissection was performed within 4-6 weeks after the completion of neoadjuvant therapy in patients without tumor progression on preoperative imaging assessment.

06

What researchers measure

Primary outcomes

  1. Complete Response Rate (CR Rate)

    The CR rate is defined as the sum of the pathological complete response rate (pCR rate) and the clinical complete response rate (cCR rate). To evaluate the preliminary efficacy of Zanidatamab in combination with Tislelizumab and chemoradiotherapy in neoadjuvant and organ-preserving treatment for patients with HER2-Positive locally advanced rectal cancer.

    Time frame: cCR rate should be assessed every 6-9 weeks following treatment initiation until completion of the 18 weeks therapy; pCR assessment in non-cCR patients following surgery (within 20 weeks after treatment initiation).

  2. Pathological Complete Response Rate (pCR Rate)

    Following completion of 9 weeks of neoadjuvant therapy, an assessment will be conducted after radical surgical treatment.

    Time frame: Within 15 weeks

  3. Progression-Free Survival (PFS)

    The time interval from the start of the first treatment (date of administration of zenidatumab or tislelizumab) to the date of the subject's first progression (PD) as assessed by the investigator using RECIST version 1.1

    Time frame: Within 2 years

Secondary outcomes

  1. Adverse events (AEs) were graded according to the NCI CTCAE version 5·0

    Adverse events and surgical safety

    Time frame: an expected average of 2 years

  2. 3-year disease-Free Survival

    The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first time.

    Time frame: an expected average of 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking 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 Jan 2026; primary completion for Jul 2028, 30 months later.

Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's planned 30 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

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

Registered
Nov 14, 2025
First posted
Nov 24, 2025
StartEst.
Jan 15, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jun 1, 2031
Last update
Nov 24, 2025
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.
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07243938
Lead sponsor
Tao Zhang
Responsible party
Tao Zhang (MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Sponsor-investigator
First posted
Nov 24, 2025
Start date
Jan 15, 2026 (estimated)
Primary completion
Jul 30, 2028 (estimated)
Completion
Jun 1, 2031 (estimated)
Last update
Nov 24, 2025

Study contacts

Zhenyu Lin, Ph.D.
Contact
whxhlzy@hust.edu.cn
027-85871982
Tao Zhang, Ph.D.
Contact
taozhangxh@hust.edu.cn
Tao Zhang, Ph.D.
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

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

Not currently enrolling

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Zanidatamab

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