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 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;
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;
Single group
Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab
DrugThe 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.
Clinical Complete Response (CCR)
absence of detectable tumor on clinical, radiological, endoscopic, and digital rectal examination
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.
surgery complications
postoperative bleeding, anastomic leak, intra abdominal and intra pelvic infection, ect.
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).
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.
Adverse Effects
Drug related adverse effects
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