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Can a drug combo make rectal cancer disappear before surgery?

NCT ID NCT07769853

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This trial tests whether a combination of two investigational drugs (QL-1706) plus chemotherapy and bevacizumab, with or without radiation, can shrink or eliminate tumors in people with locally advanced rectal cancer before surgery. The goal is to see if this neoadjuvant approach can achieve a complete response—meaning no cancer is detectable after treatment. The study will also assess safety and whether skipping radiation is a viable option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iparomlimab and Tuvonralimab (QL-1706) combined with chemotherapy and bevacizumab, with or without radiotherapy
What this could lead to
If successful, this approach could shrink or eliminate rectal tumors before surgery, potentially allowing some patients to avoid radiation or even surgery, and improve long-term outcomes.
What could go wrong
This is an early-phase, single-arm trial, so results may not be confirmed in larger studies. The combination may cause significant side effects, and not all patients will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The patient voluntarily consents to participate in this study, demonstrates good compliance, is able to meet the trial requirements for observation and follow-up, and has signed the informed consent form; * Age between 18 and 75 years, inclusive, regardless of gender (at the time of signing the informed consent); * ECOG Performance Status (PS) score of 0 or 1; * Expected survival time ≥12 weeks; * Histologically confirmed diagnosis of mid- or upper-rectal adenocarcinoma, with the tumor located 5-12 cm from the anal verge; * Colonoscopic biopsy specimens assessed by the pathology department at the study center show pMMR by immunohistochemistry or MSS by genetic testing (PCR or NGS method); * Clinical staging of cT3-4N0M0 or cTxN+M0; * No prior anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, targeted therapy, or immunotherapy); * At least one measurable lesion: the lesion must have one clearly measurable diameter (recorded as the longest diameter), with the minimum size defined as follows: * CT scan: ≥10 mm (CT slice thickness should not exceed 5 mm); * Malignant lymph nodes: must be pathologically enlarged and measurable, with a short-axis diameter of ≥15 mm on CT (recommended slice thickness ≤5 mm); * Major organ functions must be adequate, meeting the following criteria: Hematology (without hematopoietic growth factors or blood transfusion within 7 days): 1. Neutrophils ≥1.5 × 10⁹/L 2. Platelets ≥100 × 10⁹/L 3. Hemoglobin ≥90 g/L Biochemistry: e) Total bilirubin ≤1.5 × ULN f) AST and ALT ≤2.5 × ULN g) Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula) Coagulation: h) Coagulation function must meet the following conditions: INR ≤1.5 PTT or aPTT ≤1.5 × ULN \- Subjects with reproductive potential must use appropriate contraceptive methods during the study and for 120 days after its completion. Female participants must have a negative serum pregnancy test within 7 days before enrollment and must not be breastfeeding. Exclusion Criteria: * Clinical stage cT4b and low rectal cancer (tumor located less than 5 cm from the anal verge); * Prior rectal cancer surgery before enrollment, excluding stoma procedures; * History of malignancy, except for cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or early-stage thyroid cancer; * Severe hypersensitivity or allergic reactions to humanized antibodies or fusion proteins in the past; * Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception; * Diagnosed immunodeficiency or receiving systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are allowed; * Active, known, or suspected autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.) are excluded. However, patients with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions not expected to recur without an external trigger, may be enrolled; * Severe pre-existing cardiac conditions, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, or severe valvular heart disease; * Hypertension that is poorly controlled with antihypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg). Patients are eligible if BP is well controlled with treatment. Patients with a history of hypertensive crisis or hypertensive encephalopathy are excluded; * Active hepatitis B (HBV DNA ≥2000 IU/ml or 10⁴ copies/ml) or hepatitis C (positive anti-HCV antibody and HCV-RNA above detection threshold); * Active tuberculosis (TB) infection, as determined by chest X-ray, sputum test, and clinical examination. Patients with a history of active TB infection within the past year are excluded even if treated. Those with TB infection more than a year ago are also excluded unless prior anti-TB treatment was appropriate in both duration and regimen; * Major surgery, incisional biopsy, or significant traumatic injury within 28 days prior to randomization; * Imaging indicates tumor invasion of major blood vessels, or in the investigator's opinion, the tumor is likely to invade major blood vessels during the study and pose a risk of fatal hemorrhage; * Any signs or history of bleeding disorders, regardless of severity; patients who had any bleeding event ≥ Grade 3 (CTCAE) within 4 weeks prior to randomization; patients with unhealed wounds, ulcers, or fractures; * Arterial or venous thrombotic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolism) within the past 6 months; * Uncontrolled neurological or psychiatric disorders or mental illness leading to poor compliance or inability to report treatment response; * Any comorbid condition that, in the investigator's judgment, could seriously jeopardize patient safety or interfere with study completion; * Other conditions deemed inappropriate for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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