Immunotherapy combo shows promise against tough colorectal cancer
NCT ID NCT07160647
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests two immunotherapy drugs (iparomlimab and tuvonralimab) given before surgery to 29 patients with a specific genetic type of colorectal cancer (MSI-H/dMMR). The goal is to see if this combination can completely eliminate the tumor before surgery. Researchers will also study tissue samples to better understand who benefits most.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and Tuvonralimab (immunotherapy drugs targeting PD-1 and CTLA-4 proteins)
- What this could lead to
- If successful, this could offer a more effective pre-surgery treatment option for certain colorectal cancers, potentially increasing the chance of complete tumor removal.
- What could go wrong
- This is a small, early-phase study (29 participants) with no control group. The drugs may cause immune-related side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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29 people
The number who actually took part.
- Started
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Aug 2025
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients willing to receive neoadjuvant therapy. 2. Age ≥18 years. 3. Histologically confirmed primary colorectal adenocarcinoma (without squamous or sarcomatoid components). 4. Radiologically assessed (contrast-enhanced CT or MRI) as surgically resectable stage IIB-III (limited to cT4 or cN+ per AJCC 8th edition). 5. Confirmed dMMR or MSI-H status by immunohistochemistry or MSI genetic testing. 6. Lesions diagnosed by investigators as amenable to radical resection (R0 resection) without requiring multi-organ resection prior to neoadjuvant therapy. 7. Voluntary participation with signed informed consent. 8. ECOG performance status score of 0-1. 9. No prior antitumor or immunotherapy before enrollment. 10. Adequate organ and bone marrow function defined as: 1. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥7.0 g/dL. 2. Liver function: Total Bilirubin (TBIL) ≤1.5×ULN; Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST) ≤3×ULN; Serum Albumin (ALB) ≥28 g/L. 3. Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; Urine dipstick shows protein \<2+; for subjects with baseline urine dipstick protein ≥2+, a 24-hour urine collection must demonstrate protein \<1 g. 4. Coagulation: International Normalized Ratio (INR) ≤1.5 and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. 11. No severe comorbidities jeopardizing survival (life expectancy \<5 years). 12. Fertile female subjects or male subjects with fertile partners must use effective contraception during and for 6 months after treatment. Postmenopausal status or negative urine/serum pregnancy test for premenopausal females. Exclusion Criteria: * 1.Prior antitumor therapy for the disease under investigation, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2.Previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), as well as adoptive cell immunotherapy. 3.Concurrent participation in another interventional clinical study. 4.Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug. 5.Within 7 days before screening laboratory tests: receipt of blood transfusion, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin (EPO), thrombopoietin (TPO), or IL-11 therapy. 6.Use of immunosuppressive drugs within 4 weeks before the first dose of the study drug, excluding: intranasal/inhaled topical steroids or local steroid injections (e.g., intra-articular); systemic corticosteroids at doses ≤10 mg/day prednisone or equivalent; corticosteroids as premedication for allergic reactions (e.g., CT scan premedication). 7.Use of Chinese herbal medicine with antitumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 1 week before the first dose of the study drug. 8.Receipt of live or attenuated vaccines within 4 weeks before the first dose or anticipated during the study. 9.Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose, anticipated need for major surgery during the study (except protocol-defined radical resection for colon cancer), or presence of unhealed wounds, ulcers, or fractures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,
Hangzhou, Zhejiang, 310016, China