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New treatment option for Rectal Cancer Patients
Official title Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
ClinicalTrials.gov ID: NCT06911684
What this study is testing
What is lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy?
lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for rectal cancer patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of short-term radiotherapy combined with Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood, urine, feces, and tumor tissue and treatment efficacy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18-75 years.
- Pathology: Histologically confirmed rectal adenocarcinoma, with the lower tumor edge ≤12 cm from the anal verge.
- Initial Clinical Stage: cT3-4aN0M0 or cT1-4aN+M0, regardless of MRF, EMVI, or LLNM status. Preoperative staging methods: chest and abdominal CT...
- pMMR/MSS Status: pMMR confirmed by immunohistochemistry (IHC) at the study center's pathology department, or MSS/MSI-L confirmed by PCR or NGS.
- ECOG Performance Status: 0-1.
You likely can't join if
- Active Autoimmune Disease: Any active autoimmune disease requiring systemic treatment (i.e., disease-modifying medications, corticosteroids, or...
- Concurrent Systemic Therapy: Use of systemic corticosteroids (≥10 mg/day of prednisone or equivalent) or other immunosuppressants (e.g...
- Live Vaccines: Receipt of a live or attenuated live vaccine within 30 days before the first dose or potentially during the study period.
- Antibiotic Use: Administration of broad-spectrum antibiotics by any route within 30 days prior to the first dose.
- Previous Anticancer Therapies: Any prior antitumor treatments (radiotherapy, chemotherapy, surgery [excluding biopsy], PD-1/CTLA-4 dual...
- Unresectable Factors: Tumors deemed unresectable or participants with surgical contraindications, or who refuse surgery.
See the full eligibility criteria
Who can join
- Age: 18-75 years.
- Pathology: Histologically confirmed rectal adenocarcinoma, with the lower tumor edge ≤12 cm from the anal verge.
- Initial Clinical Stage: cT3-4aN0M0 or cT1-4aN+M0, regardless of MRF, EMVI, or LLNM status. Preoperative staging methods: chest and abdominal CT, pelvic MRI, endoscopic ultrasound (EUS), or transrectal ultrasonography.
- pMMR/MSS Status: pMMR confirmed by immunohistochemistry (IHC) at the study center's pathology department, or MSS/MSI-L confirmed by PCR or NGS.
- ECOG Performance Status: 0-1.
- Informed Consent: Voluntarily agrees to participate and signs the informed consent form.
- No Prior Treatment: No previous therapy targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery.
- Planned Surgery: Surgery is planned upon completion of neoadjuvant therapy.
- Expected Survival: ≥6 months.
- Adequate Organ and Bone Marrow Function, meeting all of the following (with no blood products, growth factors, or other hematopoietic-supportive medications used within 14 days before first administration): Hematology...
- Contraception: Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first study dose, and must use effective contraception (e.g., intrauterine device, oral...
- Compliance and Follow-up: Demonstrates good compliance and agrees to attend follow-up visits.
- Biological Samples: Agrees to provide blood, urine, stool, and tumor tissue samples.
What rules you out
- Active Autoimmune Disease: Any active autoimmune disease requiring systemic treatment (i.e., disease-modifying medications, corticosteroids, or immunosuppressive agents) within 2 years prior to enrollment (e.g...
- Concurrent Systemic Therapy: Use of systemic corticosteroids (≥10 mg/day of prednisone or equivalent) or other immunosuppressants (e.g., cyclosporine, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 14...
- Live Vaccines: Receipt of a live or attenuated live vaccine within 30 days before the first dose or potentially during the study period.
- Antibiotic Use: Administration of broad-spectrum antibiotics by any route within 30 days prior to the first dose.
- Previous Anticancer Therapies: Any prior antitumor treatments (radiotherapy, chemotherapy, surgery [excluding biopsy], PD-1/CTLA-4 dual immunotherapy, regorafenib, or other tyrosine kinase inhibitors).
- Unresectable Factors: Tumors deemed unresectable or participants with surgical contraindications, or who refuse surgery.
- Immunodeficiency: HIV infection, any other acquired or congenital immunodeficiency disorder, or a history of organ or allogeneic bone marrow transplantation (excluding corneal transplantation).
- Hepatitis B/C Co-infection: HBsAg-positive and/or HBcAb-positive with HBV DNA \>10\^4 copies/mL (≈2000 IU/mL). Anti-HCV antibody-positive with HCV-RNA \>10\^3 copies/mL. Patients positive for both HBsAg and HCV-RNA are...
- Other Malignancies: Any other malignancies within the past 5 years or concurrent malignancies, except for treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Uncontrolled Effusions: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.
- Severe Pulmonary Conditions: Known active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other severe pulmonary diseases/impairments.
- Renal Failure: Renal failure requiring hemodialysis or peritoneal dialysis.
- Active Infection or Fever: Active infection, unexplained fever ≥38.5°C within 7 days prior to study treatment, or baseline WBC count \>15 × 10\^9/L.
- Cardiac Conditions: Poorly controlled or clinically significant cardiac conditions, including: NYHA Class II or higher heart failure, LVEF \ 450 ms (men), or QTc \>470 ms (women)
- Hypertension: Poorly controlled (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite antihypertensive therapy, or a history of hypertensive crisis/encephalopathy.
- Recent Thrombosis: Arterial or venous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism).
- Coagulopathy: Known hereditary or acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulopathy).
- Significant Bleeding: Evidence or history of bleeding. Any Grade ≥3 hemorrhage within 4 weeks prior to study treatment (per CTCAE v5.0).
- Vascular Invasion: Tumor invasion of major blood vessels or a high likelihood thereof during the study, potentially leading to life-threatening bleeding as judged by imaging.
- Wounds or Ulcers: Severe, unhealed or dehiscent wounds, active ulcers, or untreated fractures.
- Major Vascular Disease: Major vascular disorders within 6 months prior to study treatment (e.g., requiring surgical repair for an aneurysm or recent peripheral arterial thrombosis).
- Major Surgery: Major surgery (other than diagnostic) within 4 weeks prior to study treatment, or planned major surgery during the study period (excluding the planned study-related procedure).
- Abdominal Fistula, Perforation, or Abscess: Such events within 6 months prior to study treatment.
- Long-Term NSAIDs or Anticoagulants: Need for long-term or high-dose NSAIDs (≥325 mg aspirin) or anticoagulant therapy.
- Known Drug Allergy: Suspected or known allergy to any study drug or its components relevant to this trial.
- Monoclonal Antibody Hypersensitivity: History of severe hypersensitivity reactions to any monoclonal antibody, or known hypersensitivity/allergy to QL1706, regorafenib, oxaliplatin, capecitabine, or any of their...
- Difficulty Swallowing: Inability or difficulty swallowing oral study drugs.
- Pregnant or Breastfeeding: Women who are pregnant or lactating.
- Other Factors: Any other factors that may affect study outcomes or lead to premature termination, including a history of alcohol or drug abuse, severe diseases (including psychiatric disorders) requiring combination...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.