New combo therapy aims to boost remission in tough rectal cancer
NCT ID NCT07527520
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new approach for high-risk locally advanced rectal cancer. It combines a shorter course of radiation with chemotherapy (capecitabine and oxaliplatin) and an immunotherapy drug (serplulimab). The study will compare this combo to standard chemoradiation in 165 patients to see if it leads to higher complete remission rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Moderately hypofractionated radiotherapy, capecitabine, oxaliplatin, and serplulimab
- What this could lead to
- If successful, this could offer a more effective and shorter treatment option for patients with high-risk locally advanced rectal cancer, potentially increasing the chance of complete remission.
- What could go wrong
- This is a phase 2 trial with only 165 participants, so results are preliminary. The combination of treatments may increase side effects, and it is not yet known if it will improve long-term survival.
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 165 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
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 years and ≤ 75 years. * Histologically confirmed colorectal adenocarcinoma with the lower margin of the lesion ≤ 10 cm from the anal verge as assessed by MRI, and immunohistochemistry confirming pMMR, or genetic testing demonstrating MSI-L or MSS. * Presence of at least one of the following high-risk factors as assessed by pelvic MRI: cT4a/b; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph node (longest diameter \> 7 mm). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 * No prior surgery, radiotherapy, chemotherapy, or targeted therapy. * Able to tolerate radiotherapy, chemotherapy, and immunotherapy: ECOG performance status score 0-2. Laboratory results: white blood cell count ≥ 4.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 80 g/L, ALT \< 2 × ULN, total bilirubin \< 35 μmol/L, serum creatinine \< 1.5 × ULN or creatinine clearance ≥ 50 mL/min, thyroid-stimulating hormone within normal range (patients with stable thyroid function after hormone replacement therapy may be enrolled). * Willing to participate and able to provide written informed consent. Exclusion Criteria: * Presence of distant metastasis. * Patients with stage I or II rectal cancer who do not require preoperative neoadjuvant therapy. * Severe diseases involving the heart, lung, brain, kidney, gastrointestinal tract, or other systemic conditions. * Untreated chronic hepatitis B or HBV carriers with HBV DNA \> 500 IU/mL, or patients positive for HCV RNA. Patients with inactive hepatitis B surface antigen (HBsAg) carriers, those with hepatitis B who have been treated and are stable (HBV DNA \< 500 IU/mL), and those who have been cured of hepatitis C may be enrolled. * Active autoimmune disease or history of autoimmune disease with potential for relapse. * Receipt of corticosteroids (at a dose equivalent to prednisone \> 10 mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration. * History of thyroid dysfunction. * Severe chronic or active infection requiring systemic antifungal or antiviral therapy, including tuberculosis infection. * History of allergic constitution or allergy to multiple drugs. * History of prior pelvic radiotherapy. * History of inflammatory bowel disease. * Unwillingness to participate or inability to provide written informed consent.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Zhongshan hosptial, Fudan University
Shanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?