ClinicalTrials.gg
Not yet recruitingNCT07649473Updated Jun 16, 2026

QL1706 Combined With Standard Therapy for Conversion Therapy of Synchronous Liver Metastases From Colon Cancer: a Multicenter, Single-arm, Exploratory Study

A Phase 2 interventional study of QL1706 (Iparomlimab/Tuvonralimab) in Colon Cancer and Synchronous Liver Metastases, sponsored by Fujian Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Fujian Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a single-arm clinical study aiming to enroll 30 colon cancer patients with liver-only metastases. All eligible participants will undergo screening and enrollment after signing the informed consent form.

All patients will receive stereotactic body radiation therapy (SBRT) targeting 1 to 3 liver lesions (each \< 3 cm) at a total dose of 50 Gy delivered in 5 fractions. For lesions adjacent to the liver capsule, portal vein or bile duct, the target volume can be expanded by 5-10 mm outside the visible lesion boundary. One week after radiotherapy completion, patients will be treated with QL1706 (Apalitamab-Tovorizumab, 5 mg/kg, iv, Q3W) combined with CAPOX plus bevacizumab.

Preoperative treatment consists of up to 6 cycles, with each cycle lasting 3 weeks. Efficacy assessment will be conducted every 2 cycles. The investigator or multidisciplinary team (MDT) will decide to initiate curative treatment (surgical resection or radiofrequency ablation of liver metastases, combined with synchronous or staged resection of primary colon lesion) or continue conversion therapy. Surgery shall be scheduled 6 weeks after the final dose of bevacizumab. During the preoperative waiting period, one extra cycle of QL1706 (5 mg/kg, iv, Q3W) plus CAPOX is permitted. The interval between the last immunochemotherapy administration and surgery is required to be 2-3 weeks.

Adjuvant therapy is scheduled to start 3 weeks after surgery, and must be initiated no later than 2 months postoperatively. The investigator will determine the use of QL1706 and/or bevacizumab in adjuvant setting according to individual patient conditions. If the time from surgery to adjuvant therapy is less than 4 weeks, the first postoperative cycle will use QL1706 (5 mg/kg, iv, Q3W) combined with CAPOX only. Postoperative QL1706 maintenance treatment will not exceed 1 year. Patients receiving postoperative systemic adjuvant chemotherapy will complete 8 cycles of perioperative CAPOX with or without bevacizumab.

Patients with progressive disease (PD) or those who fail conversion therapy within 18 weeks will switch to alternative systemic regimens in accordance with the 2025 guidelines issued by the Chinese Society of Clinical Oncology (CSCO) and the National Comprehensive Cancer Network (NCCN).

CAPOX + bevacizumab regimen (repeated every 3 weeks):

Oxaliplatin: 130 mg/m², intravenous infusion over 2 hours, d1; Capecitabine: 1000 mg/m² per dose, po, bid, d1-14; Bevacizumab: 7.5 mg/kg, ivgtt, d1.

02

Conditions studied

  • Colon Cancer
  • Synchronous Liver Metastases

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Keywords

  • QL1706
  • colon cancer
  • synchronous liver metastases
  • conversion
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 30 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 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

  • Aged 18 to 70 years, male or female.
  • (ECOG) performance status score of 0 or 1.
  • or cytologically confirmed colon adenocarcinoma, with pathologically or radiographically verified liver-only .
  • Microsatellite stable (MSS) / proficient mismatch repair (pMMR) confirmed by immunohistochemistry (IHC) or polymerase chain reaction (PCR).
  • No prior local or systemic anti-tumor therapy for colon cancer liver metastases, including but not limited to targeted therapy, immunotherapy, systemic or hepatic arterial infusion chemotherapy, radiotherapy and surgery.
  • Inclusion criteria for liver metastases: ① More than 5 liver metastatic lesions, with at least one lesion measuring less than 3 cm in diameter; ② Class A; ③ Future Liver Remnant (FLR) / Standard Liver Volume (SLV) > 30% for patients without liver cirrhosis, or > 40% for patients with liver cirrhosis; ④ Exclude lesions involving complicated surgical sites, such as biliary tract reconstruction, vascular reconstruction, invasion of hepatic hilum, portal vein or inferior vena cava.
  • At least one radiographically per Version 1.1 (RECIST 1.1).
  • Expected survival of no less than 12 weeks.
  • Laboratory test results meet the following criteria within 7 days prior to the first study drug administration (No blood products, hematopoietic growth factors, albumin or other corrective medications deemed necessary by the investigator shall be administered within 14 days before testing):

    1. Biochemistry: Alkaline phosphatase (ALP), (ALT) and aspartate transaminase (AST) ≤ 3 × (ULN), or ≤ 5 × ULN in patients with liver metastases; Total (TBIL) ≤ 1.5 × ULN, or ≤ 2 × ULN in patients with liver metastases; Serum creatinine ≤ 1.5 × ULN, or > 50 mL/min (calculated via Cockcroft-Gault formula).
    2. Hematology: (Hb) ≥ 9.0 g/dL; No red blood cell transfusion within 1 week (including the test day) before baseline Hb test; (ANC) ≥ 1.5 × 10⁹/L; count ≥ 100 × 10⁹/L; No platelet transfusion within 1 week (including the test day) before baseline platelet test.
    3. Coagulation function: (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For subjects receiving prophylactic anticoagulation without active bleeding (no bleeding within the past 14 days), INR ≤ 2 × ULN and APTT within normal range.
    4. Urinalysis: Urinary protein ≤ 30 mg/dL (1+) by dipstick or routine urinalysis. If urine protein ≥ 2+, 24-hour urinary protein quantification shall be less than 1 g/24h.
  • No to radiotherapy, chemotherapy or immunotherapy.
  • For female subjects of : serum pregnancy test must be negative within 7 days prior to enrollment. They must agree to use effective throughout the study and for 5 months after the last study drug administration. Male subjects with partners of childbearing potential must also use effective contraception during the study and for 5 months after the last dose. Lactating women are excluded.
  • Subjects must be fully informed of the study prior to enrollment, voluntarily sign the written form, and be willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Confirmed non-adenocarcinoma pathological types via histopathology or cytopathology, including squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc. For mixed pathological types, eligibility is determined by the predominant component; patients are eligible only if a pathologist confirms the adenocarcinoma component accounts for more than 70%. Patients with primary appendiceal tumors are excluded.
  • Presence of distant at sites other than the liver.
  • Prior systemic treatment with , anti-PD-L1, anti-CTLA-4 antibodies or other immunotherapeutic agents, or the CAPOX regimen. Prior radiotherapy for liver metastases, or prior radiation exposure to normal liver tissue adjacent to the planned irradiation field.
  • History of other malignant tumors within 5 years prior to enrollment, except cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, radically treated localized prostate cancer, and radically treated ductal carcinoma in situ.
  • Active diseases requiring systemic treatment (with immunomodulators, or ) within the past 2 years. Replacement therapies such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency are permitted and not regarded as systemic immunosuppressive treatment.
  • Immunodeficiency, or receipt of long-term systemic corticosteroids (prednisone equivalent > 10 mg per day) or other immunosuppressants within 7 days before enrollment or anticipated during study treatment.
  • Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites.
  • Tumor-related complications such as bleeding, perforation or intra-abdominal infection within 3 months prior to enrollment.
  • bleeding symptoms or high bleeding risk within 3 months prior to enrollment, including gastrointestinal hemorrhage, gastroesophageal varices, bleeding gastric ulcer, hematochezia, hematemesis or hemoptysis. Presence of gastrointestinal disorders including active peptic ulcer, ulcerative colitis, gastrointestinal perforation, unhealed gastrointestinal fistula, malabsorption syndrome or uncontrolled inflammatory bowel disease.
  • Thrombotic or thromboembolic events including cerebrovascular accident, pulmonary embolism and deep vein thrombosis within 6 months prior to enrollment.
  • Medical history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia or interstitial lung disease; or evidence of active pneumonia detected on contrast-enhanced chest CT.
  • Any significant clinical or laboratory abnormalities judged by the investigator to compromise safety assessment, including uncontrolled active infection, poorly controlled diabetes, hypertension unresponsive to single-agent therapy, Grade ≥ 2 peripheral neuropathy, congestive heart failure, (NYHA) Class ≥ II cardiac disease, myocardial infarction within 3 months prior to enrollment, unstable arrhythmia, unstable angina, chronic kidney disease and thyroid dysfunction.
  • Major surgery performed within 28 days prior to enrollment without complete postoperative recovery.
  • Active infection requiring systemic oral or intravenous treatment within 2 weeks prior to enrollment (excluding viral hepatitis and prophylactic medication).
  • Patients with active tuberculosis, or those who received anti-tuberculosis therapy within 1 year prior to enrollment.
  • For patients positive for surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV-DNA must be less than 500 IU/mL. Patients with active hepatitis B must have received antiviral therapy for at least 14 days before enrollment (e.g., entecavir or tenofovir per local guidelines) and agree to continue effective antiviral treatment throughout the study. For patients positive for antibody, HCV-RNA testing is required; those with HCV-RNA > 1000 copies/mL will be excluded.
  • Positive (HIV) antibody.
  • Administration of any (e.g., influenza vaccine, varicella vaccine) within 28 days prior to enrollment.
  • Prior bone marrow transplantation or solid organ transplantation.
  • Known allergy to any study drug or its .
  • History of uncorrected serum electrolyte disorders (e.g., hypokalemia, hypocalcemia, hypomagnesemia).
  • Participation in other interventional clinical studies within 28 days prior to enrollment.
  • Presence of clinically significant underlying diseases or other conditions judged by the investigator to interfere with study drug administration or protocol compliance.
Terms in these criteria, in plain language(30)

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.

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.

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.

Metastases

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

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

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.

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

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

Study arms

  • Experimental
    Experimental

    Patients receive SBRT for 1-3 liver metastases (each lesion \<3 cm) at a dose of 50 Gy in 5 fractions. For lesions adjacent to the liver capsule, portal vein or bile duct, the target volume is expanded by 5-10 mm beyond the visible lesion margin. One week after radiotherapy, patients are treated with QL1706 (Apalitamab-Tovorizumab; 5 mg/kg, iv, Q3W) combined with CAPOX plus bevacizumab. Patients receive up to 6 preoperative 3-week treatment cycles, with efficacy evaluation performed every 2 cycles. The investigator or MDT team decides subsequent management, including curative treatment (surgical resection or radiofrequency ablation of liver metastases with synchronous or staged intestinal lesion resection) or continuous conversion therapy. Surgery is scheduled 6 weeks after the last bevacizumab dose. One additional cycle of QL1706 plus CAPOX may be given during the preoperative waiting period, with a 2-3-week interval between the end of chemoimmunotherapy and surgery.

    Drug: QL1706 (Iparomlimab/Tuvonralimab)

Interventions

  • DrugQL1706 (Iparomlimab/Tuvonralimab)

    Drug page: Iparomlimab/Tuvonralimab

    Patients receive SBRT for 1-3 liver metastases (each lesion \<3 cm) at a dose of 50 Gy in 5 fractions. For lesions adjacent to the liver capsule, portal vein or bile duct, the target volume is expanded by 5-10 mm beyond the visible lesion margin. One week after radiotherapy, patients are treated with QL1706 (Apalitamab-Tovorizumab; 5 mg/kg, iv, Q3W) combined with CAPOX plus bevacizumab. Patients receive up to 6 preoperative 3-week treatment cycles, with efficacy evaluation performed every 2 cycles. The investigator or MDT team decides subsequent management, including curative treatment (surgical resection or radiofrequency ablation of liver metastases with synchronous or staged intestinal lesion resection) or continuous conversion therapy. Surgery is scheduled 6 weeks after the last bevacizumab dose. One additional cycle of QL1706 plus CAPOX may be given during the preoperative waiting period, with a 2-3-week interval between the end of chemoimmunotherapy and surgery.

06

What researchers measure

Primary outcomes

  1. Rate of R0 Resection and Complete Ablation

    The proportion of participants who achieve both R0 resection (no residual tumor at the resection margin) and complete ablation (no evidence of residual ablated disease on imaging) as assessed by postoperative pathology and imaging at 1 month postoperatively.

    Time frame: 1 month postoperatively

Secondary outcomes

  1. Conversion Success Rate

    The proportion of participants with initially unresectable disease who are successfully converted to resectable status and undergo curative-intent surgical resection. Resectability is assessed by a multidisciplinary team (MDT) based on radiographic imaging per RECIST 1.1 criteria and clinical evaluation, with confirmation of completed surgery at 1 month postoperatively.

    Time frame: 1 month postoperatively

  2. Objective Response Rate

    The proportion of participants achieving a complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by imaging at 6 months after study completion.

    Time frame: 6 months after study completion

  3. Disease Control Rate

    The proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria, assessed by imaging at 6 months after study completion.

    Time frame: 6 months after study completion

  4. Event Free Survival

    Time from study enrollment to the first occurrence of any of the following events: disease recurrence, disease progression, death from any cause, or treatment-related serious adverse event leading to discontinuation, assessed up to 5 years after study completion.

    Time frame: 5 years after study completion

  5. tumor regression grade

    Histopathologic tumor regression grade in resected specimens, categorized per the AJCC system, assessed by central pathology review at 1 month postoperatively.

    Time frame: 1 month postoperatively

  6. Disease Free Survival

    Time from surgery to the first documented disease recurrence (local, regional, or distant) or death from any cause, assessed up to 5 years postoperatively.

    Time frame: 5 years postoperatively

  7. overall survival

    Time from study enrollment to death from any cause, assessed up to 5 years after study completion.

    Time frame: 5 years after study completion

  8. Health-Related Quality of Life (HRQoL) assessed by EORTC QLQ-C30

    Patient-reported health-related quality of life measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), including global health status and functional scales, administered at baseline and scheduled follow-up time points up to 5 years after study completion.

    Time frame: 5 years after study completion

  9. Adverse Events

    Treatment-emergent adverse events (TEAEs) are defined as any untoward medical occurrence that develops or worsens in severity after the start of study treatment, up to 30 days following surgical resection. All events will be graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0, and categorized by system organ class. The incidence of participants experiencing at least one TEAE will be summarized.

    Time frame: 30 days after treatment completion

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — The individual participant data (IPD) sharing plan for this study has not been finalized. The decision regarding IPD sharing will be determined after the completion of the study data analysis, summary report compilation, and comprehensive assessment of data confidentiality, patient privacy protection, relevant institutional regulations, and sponsor policy.

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 Aug 2026; primary completion for Dec 2028, 28 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 28 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
Jun 1, 2026
First posted
Jun 16, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2033
Last update
Jun 16, 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.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07649473
Responsible party
Xi Shi (MD, Fujian Medical University) — Principal investigator
First posted
Jun 16, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Jun 16, 2026

Study contacts

Xi Shi, MD
Contact
sxi1991@fjmu.edu.cn
+8613960769368

Oversight

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

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Discussion

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Studies of the drug tested here: Iparomlimab/Tuvonralimab

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