New triple therapy aims to shrink rectal tumors and avoid surgery
NCT ID NCT07175636
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new approach for people with locally advanced rectal cancer that is not responding well to standard immunotherapy. Participants will receive short-course radiation, followed by an experimental drug (QL1706) that boosts the immune system, plus chemotherapy. The goal is to see if this combination can completely eliminate the tumor before surgery, and possibly allow some patients to avoid surgery altogether.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL1706 (an experimental antibody targeting PD-1 and CTLA-4) combined with mFOLFOX6 chemotherapy and short-course radiotherapy
- What this could lead to
- If successful, this combination could offer a more effective way to shrink tumors before surgery, potentially allowing some patients to avoid surgery altogether and preserve their rectum.
- What could go wrong
- This is an early-phase trial with only 66 participants, so results may not apply to everyone. The experimental drug QL1706 is new, and combining it with radiation and chemotherapy could cause significant side effects.
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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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
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 to 75 years
- 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: Age 18-75 years, male or female. Histologically confirmed rectal adenocarcinoma. Locally advanced disease (cT3-4 and/or N+, M0) based on pelvic MRI and/or CT. Tumor located within 12 cm from the anal verge. Proven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status. ECOG performance status 0-1. Adequate organ function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L ALT/AST ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min No prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer. Signed written informed consent Exclusion Criteria: Evidence of distant metastasis. Previous or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ). Active autoimmune disease requiring systemic immunosuppressive therapy. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis. Known allergy or hypersensitivity to study drugs or excipients. Uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia). Pregnant or breastfeeding women. Any condition judged by investigators to make the patient unsuitable for the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a drug combo make rectal cancer disappear before surgery?
- Can a gut bacteria transplant help immunotherapy wipe out rectal cancer before surgery?
- New combo therapy aims to shrink rectal tumors before Surgery—Could spare some patients the knife
- New combo therapy aims to spare organs in High-Risk rectal cancer