Triple threat: radiation, chemo, and immunotherapy join forces against advanced rectal cancer
NCT ID NCT06787183
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether a short course of radiation followed by two cycles of chemotherapy (CAPOX) plus an experimental immunotherapy drug (QL1706) can help people with rectal cancer that has spread to the liver. The study will enroll 42 adults aged 18-75 who have not had prior treatment. The main goal is to see how long the cancer stays under control, while also monitoring side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL1706 (a bispecific antibody targeting PD-1 and CTLA-4), capecitabine, oxaliplatin, and short-course radiotherapy
- What this could lead to
- If successful, this combination could offer a new, more effective treatment option for people with rectal cancer that has spread to the liver, potentially improving how long they live without the cancer growing.
- What could go wrong
- This is a small, early-phase trial (42 people) with no control group, so results may not apply broadly. The combination of radiation, chemotherapy, and immunotherapy can cause significant side effects, including severe immune-related reactions.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Age 18-75 years, any gender. 2. Pathologically confirmed rectal cancer with liver metastases (stage M1). 3. Karnofsky Performance Status ≥70. 4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy. 5. Microsatellite/mismatch repair status MSS/pMMR. 6. No prior chemotherapy or any other anti-tumor treatment before inclusion. 7. No prior immunotherapy. 8. Ability to comply with the study protocol during the study period. 9. Signed written informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. Pathological diagnosis of signet ring cell carcinoma. 3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. 4. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication. 5. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months. 6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. 7. Patients with autoimmune diseases. 8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. 9. Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L. 10. Known deficiency of dihydropyrimidine dehydrogenase (DPD). 11. Allergy to any investigational drug components.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced rectal cancer with liver metastases are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
Contacts and locations
Locations
-
Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, 350014, China
-
Fuzhou First General Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350004, China