Can a targeted radiation combo boost rectal cancer remission?
NCT ID NCT07057089
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial is testing whether a more focused radiation field, combined with chemotherapy and an immunotherapy drug called camrelizumab, can improve outcomes for people with a certain type of locally advanced rectal cancer. The study will compare this new approach to a standard treatment that uses a larger radiation field. The main goal is to see if the new combination leads to a higher rate of complete response, meaning the cancer disappears or shrinks significantly before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of capecitabine (chemotherapy), camrelizumab (PD-1 inhibitor immunotherapy), and involved-field radiation therapy, followed by surgery.
- What this could lead to
- If successful, this approach could increase the chance of eliminating the tumor before surgery, potentially allowing some patients to avoid surgery or preserve more organs.
- What could go wrong
- This is a phase 2 trial with a relatively small number of participants. The combination may not improve outcomes and could increase side effects compared to standard treatment.
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 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 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. Age ≥18 years old, male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type; 4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria); 5. The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge; 6. Pre-enrollment laboratory indicators meet the following indicator ranges: 1)Blood: absolute neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L; 2)Liver and kidney function: ALT/AST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL/min (Cockcroft-Gault formula); 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation); 7. Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session; 8. Voluntary written informed consent and commitment to complete the full treatment and follow-up program. Exclusion Criteria: 1. Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc; 2. Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer; 3. Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy); 4. Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy); 5. Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg); 6. History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years); 7. Uncontrolled diabetes mellitus (HbA1c \> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention); 8. Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis); Patients deemed by the investigator to be unsuitable for participation in this 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 places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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the Fourth Hospital of Hebei Medical University
Shijiazhuang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an immunotherapy cocktail make rectal tumors disappear before surgery?
- Could cutting one amino acid make rectal cancer treatment more effective?
- Can a short burst of radiation plus triple chemotherapy wipe out rectal cancer before surgery?
- MRI-Guided radiation boosts hopes for rectal cancer patients
- Timing of chemo may boost rectal cancer remission