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New treatment option for Rectal Malignant Neoplasms
Official title Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
ClinicalTrials.gov ID: NCT07026422
What this study is testing
What is Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy?
Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy is an investigational medicine, being studied as a potential treatment for rectal malignant neoplasms.
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
- In colorectal cancer (CRC), ICIs show strong therapeutic associations with microsatellite instability-high (MSI-H) status, while patients with proficient mismatch repair/microsatellite stable (pMMR/MSS) tumors exhibit poor responses. Dual immunotherapy may represent a promising strategy for MSS populations.
- Phase 2: a mid-size study of how well it works
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 old, male and female
- Histologically confirmed pMMR/MSS rectal adenocarcinoma, defined by MRI as clinical stage II (T3-4, N-) or stage III (any T, N+)
- Tumor within 12 cm of the anal verge with at least one of the following high-risk factors: cT4, cN2, extramural vascular invasion [EMVI+], mesorectal...
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- No evidence of distant metastases based on chest and abdominal CT or whole body PET-CT examinations
You likely can't join if
- dMMR or MSI-H patients
- Myelosuppression without obvious causes
- Locally advanced rectal cancer without high-risk factors
- Prior or concurrent other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix)
- Severe allergic reaction to other monoclonal antibodies
- Uncontrolled cardiac clinical symptoms or disease
See the full eligibility criteria
- Age 18-75 years old, male and female
- Histologically confirmed pMMR/MSS rectal adenocarcinoma, defined by MRI as clinical stage II (T3-4, N-) or stage III (any T, N+)
- Tumor within 12 cm of the anal verge with at least one of the following high-risk factors: cT4, cN2, extramural vascular invasion [EMVI+], mesorectal fascia involved [MRF+], lateral lymph node [LN+], tumor deposit, or...
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- No evidence of distant metastases based on chest and abdominal CT or whole body PET-CT examinations
- No other rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, neuroendocrine carcinoma, etc.) or synchronous colon cancer
- Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.
- dMMR or MSI-H patients
- Myelosuppression without obvious causes
- Locally advanced rectal cancer without high-risk factors
- Prior or concurrent other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix)
- Severe allergic reaction to other monoclonal antibodies
- Uncontrolled cardiac clinical symptoms or disease
- Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents
- Abnormal coagulation (INR\>1.5 or PT\>16s), bleeding tendency or on thrombolytic or anticoagulant therapy
- Known history and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, or severely impaired lung function
- Known history of prior antitumor therapy, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T-cell related therapy, etc.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1-2 antibody-positive), active syphilis infection, active tuberculosis infection, or active hepatitis B virus or hepatitis C virus infection at...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 Jinan, Shandong, 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.