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Can a targeted radiation combo boost rectal cancer remission?

NCT ID NCT07057089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • the Fourth Hospital of Hebei Medical University

    Shijiazhuang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.