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Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC

ConditionRectal Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongnan Hospital

About this trial

This study is a single-center, prospective, single-arm, open-label, Phase II clinical trial designed to evaluate the efficacy of radiotherapy combined with CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood and tumor tissue and treatment efficacy.

Eligible participants (locally advanced rectal cancer) received pelvic radiotherapy (36 Gy/12 fractions; adaptive boost 6 Gy/2 fractions to GTVp/GTVn permitted) with one cycle of concurrent CAPOX during the first week (oxaliplatin 100 mg/m² IV D1; capecitabine 850 mg/m² PO bid). Two weeks after radiotherapy, four cycles of immunotherapy plus chemotherapy were given (iparomlimab and tuvonralimab 5 mg/kg IV D1; oxaliplatin 130 mg/m² IV D1; capecitabine 1000 mg/m² PO bid D1-14, Q3W). Two to three weeks after immunochemotherapy, surgery was performed (TME or intersphincteric resection with sphincter preservation (ISR) ), followed by adjuvant CAPOX. The primary endpoint was pathological complete response (pCR) rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neutrophils ≥1.5×10⁹/L, platelets ≥75×10⁹/L, and hemoglobin ≥9 g/dL

Total bilirubin ≤1.5×Upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤2.5×UNL (≤5×UNL if liver metastasis occurs); alkaline phosphatase ≤2.5×UNL (≤5×UNL if liver metastasis occurs, ≤10×UNL if bone metastasis occurs); LDH <1500 U/L

Creatinine clearance (calculated according to the Cockcroft and Gault formula) >60 mL/min or serum creatinine ≤1.5×UNL; (8) Voluntarily participate in this study and sign the informed consent form

Disqualifiers

(1) Histopathological examination confirms the presence of other pathological types, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.

Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (Class 2 or above as determined by the New York Heart Association functional classification) within 6 months prior to randomization, symptomatic or poorly controlled arrhythmia

3 years prior to first use of the drug a. History of pulmonary embolism or other serious thromboembolism within the past month

Presence of aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis or other major vascular diseases that may endanger life or require surgery within the past 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • lparomlimab and Tuvonralimab Injection and CPAOX and radiotherapy

    Combination product

    Patients received pelvic radiotherapy (36 Gy/12 fractions; adaptive boost 6 Gy/2 fractions to GTVp/GTVn permitted) with one cycle of concurrent CAPOX during the first week (oxaliplatin 100 mg/m² IV D1; capecitabine 850 mg/m² PO bid). Two weeks after radiotherapy, four cycles of immunotherapy plus chemotherapy were given (iparomlimab and tuvonralimab 5 mg/kg IV D1; oxaliplatin 130 mg/m² IV D1; capecitabine 1000 mg/m² PO bid D1-14, Q3W). Two to three weeks after immunochemotherapy, surgery was performed (TME or intersphincteric resection with sphincter preservation (ISR) ), followed by adjuvant CAPOX. The primary endpoint was pathological complete response (pCR) rate.

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: Group AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response (CR)

Complete response: Pathological complete response and clinical complete response

Time frame
1 year

Secondary outcomes

1

R0 Resection Rate

The proportion of surgical patients who achieve an R0 resection. R0 resection: All gross disease has been removed, and microscopic examination reveals all surgical margins free of tumor.

Time frame
1 year
2

Organ Preservation Rate (OPR)

The 1-year organ preservation rate is the percentage of patients attaining a complete clinical response (cCR) or near-complete clinical response (near-cCR) following neoadjuvant therapy, who then proceeded with non-surgical management or local excision, was monitored under a Watch \& Wait strategy or for 1 year post-local resection without undergoing radical surgery.

Time frame
1 year
3

Disease-free survival (DFS)

DFS is defined as the time from randomization to the earliest occurrence of any of the following events: Tumor progression by imaging according to RECIST 1.1, Tumor recurrence (local or distant), confirmed by imaging or biopsy, for patients with no residual tumor after surgery, Death from any cause. Note: A second primary malignancy is not considered an DFS event.

Time frame
3 years
4

Overall survival (OS)

The time interval between the date of randomization to the date of death. If the patient has been alive, the time until the last follow-up is taken as the overall survival period.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongnan Hospital

Lead sponsor

Source ClinicalTrials.gov
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