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Locally Advanced Rectal Cancer (LARC)IT-CABLENCT07769853

Iparomlimab and Tuvonralimab Combined With Chemotherapy and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

A study testing Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab in people with Locally Advanced Rectal Cancer (LARC) and 5-12cm to Anal Verge, run by Zhejiang University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aims to observe and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab（QL-1706） combined with chemotherapy and bevacizumab ± radiotherapy as neoadjuvant therapy in patients with locally advanced rectal cancer, and to explore the value and implications of radiotherapy omission in this setting. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 12 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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):
  • Neutrophils ≥1.5 × 10⁹/L
  • Platelets ≥100 × 10⁹/L
  • Hemoglobin ≥90 g/L
  • Biochemistry:
  • 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:
  • 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.

Who cannot join

  • 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;
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  • 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.

About this study

Official title: Iparomlimab and Tuvonralimab（QL-1706）Combined With Chemotherapy and Bevacizumab With or Without Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer：A Multicenter, Single Arm Clinical Trial

This study aims to observe and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab（QL-1706） combined with chemotherapy and bevacizumab ± radiotherapy as neoadjuvant therapy in patients with locally advanced rectal cancer, and to explore the value and implications of radiotherapy omission in this setting.

Read the detailed description

Colorectal cancer is the third most common cancer globally and the second leading cause of cancer-related death. For patients with T3-4/N+ locally advanced rectal cancer (LARC) without distant metastasis, achieving curative treatment while preserving organ function remains a significant challenge.

The current standard treatment for LARC is neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision (TME) surgery, aimed at reducing the risk of local recurrence. However, the overall complete response (CR) rate-including both cCR and pathologic complete response (pCR)-remains low. In addition, radiotherapy is detrimental to younger patients or women desiring fertility preservation, as pelvic radiotherapy can compromise fertility. Also, radiotherapy may reduce bone marrow reserve and impair tolerance to subsequent chemotherapy.

Recent studies have suggested that neoadjuvant chemotherapy alone is non-inferior to neoadjuvant chemoradiotherapy to avoid radiotherapy related adverse effects. On the other hand, a combination of chemotherapy and immune checkpoint blockers have shown synergistic anti-tumor effects. QL1706 (also known as PSB205) is an innovative bispecific MabPair™ antibody that simultaneously targets two immune checkpoint proteins-PD 1 (as IgG4) and CTLA 4 (as IgG1)-co expressed in a fixed ratio from a single cell line.

This study aims to observe and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab（QL-1706） combined with chemotherapy and bevacizumab ± radiotherapy as neoadjuvant therapy in patients with locally advanced rectal cancer, and to explore the value and implications of radiotherapy omission in this setting.

The inclusion criteria: 5-12cm, rectal adenocarcinoma, cT3-4N0M0 or cTxN+M0, pMMR or MSS. The primary endpoints are: Clinical Complete Response (CCR) and Pathological Complete Response (pCR). The secondary endpoints are: surgery complications, 3-year disease-free survival, 3-year event-free survival, safety and quality of life.

Being tested
Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and BevacizumabDrug

    Also called Radiotherapy, Surgery

    The QL1706 dosage is 5 mg/kg, administered via intravenous infusion once every 3 weeks, for a total of 4 doses, or until intolerable toxicity occurs or the subject withdraws informed consent.

    The bevacizumab injection dosage is 7.5 mg/kg, administered via intravenous infusion once every 3 weeks, for a total of 4 doses, or until intolerable toxicity occurs or the subject withdraws informed consent.

    Within 21 days after completing the 4th cycle of adjuvant treatment, the patient will be evaluated to determine whether additional radiotherapy would be required before surgery.

Study groups in NCT07769853
Study groupRoleWhat they receive
Experimental groupExperimentalNot described
Receives: Drug: Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Complete Response (CCR)

    absence of detectable tumor on clinical, radiological, endoscopic, and digital rectal examination

    Measured: 3 weeks After last round of neoadjuvant treatment

  2. Pathological Complete Response (pCR)

    Pathological Complete Response means no residual viable tumor cells in the surgical specimen, including both the primary tumor site and regional lymph nodes, after neoadjuvant therapy and surgery.

    Measured: 1 month after surgery

Secondary outcomes (5)

  1. surgery complications

    postoperative bleeding, anastomic leak, intra abdominal and intra pelvic infection, ect.

    Measured: up to 6 weeks after surgery

  2. 3-year disease-free survival

    The proportion of patients who remain alive and free of any signs or symptoms of the original cancer (no recurrence or metastasis) for three years after treatment (usually surgery or curative therapy).

    Measured: 3 years after surgery

  3. 3-year Event-Free Survival (EFS)

    The proportion of patients who do not experience any predefined "event" (such as progression, recurrence, new cancer, or death) within three years of treatment initiation.

    Measured: 3 years after surgery

  4. Adverse Effects

    Drug related adverse effects

    Measured: 3 months after surgery

  5. Quality of Life Score

    Quality of Life Score measured on a QoL scale

    Measured: 3 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion12 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769853
Sponsor's protocol ID
IT-CABLE QL-1706
Acronym
IT-CABLE
Status last verified
Aug 2026
First submitted
2 Jul 2025
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab in people with Locally Advanced Rectal Cancer (LARC) and 5-12cm to Anal Verge, run by Zhejiang University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Complete Response (CCR) (time frame: 3 weeks After last round of neoadjuvant treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07769853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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