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Rectal Cancer, AdenocarcinomaPhase 2NCT07397442

Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer

A Phase 2 study testing Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy in people with Rectal Cancer, Adenocarcinoma and Rectal Cancer Stage II, run by Beijing Friendship Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to test a new combination treatment for locally advanced rectal cancer (cancer in the lower or middle part of the rectum that has not spread to distant organs). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
1 Mar 2026to 28 Feb 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years.
  • ECOG performance status score 0-2.
  • Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS.
  • Imaging studies confirm no distant metastasis or lateral lymph node metastasis; MRI staging is II/III (excluding T4b, N1c, N2) and any positive lymph nodes (if present) are confined within the mesorectum.
  • MRI shows the distal margin of the tumor is ≤10 cm from the anal verge, and the mesorectal fascia (MRF) is negative.
  • The longest diameter of the rectal cancer lesion is ≥10 mm on baseline CT or MRI (meeting the definition of a "measurable lesion" per RECIST 1.1 criteria).
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  • Willing and able to comply with the study procedures.
  • Consent to the use of tissue and blood samples by the investigator for medical research purposes.
  • No prior history of radiotherapy or immunotherapy.
  • No history of immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, ulcerative colitis, HIV infection, etc.).
  • No history of endocrine system diseases (e.g., hyperthyroidism, hypothyroidism, thyroid nodules, thyroiditis, type 1 diabetes, type 2 diabetes, gestational diabetes, other specific types of diabetes, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal insufficiency, pituitary adenoma, anterior pituitary hypofunction, acromegaly, gigantism, polycystic ovary syndrome, precocious puberty, hypogonadism, hyperparathyroidism, hypoparathyroidism, etc.).
  • No severe cardiac, pulmonary, hepatic, or renal dysfunction.
  • No jaundice or gastrointestinal obstruction.
  • No concurrent acute infection.
  • Subjects must undergo all required baseline laboratory assessments, and results must be obtained within 1 week before enrollment. Laboratory values must meet the following criteria (per CTCAE 5.0):
  • White blood cell count ≥2000/μL.
  • Neutrophil count ≥1500/μL.
  • Platelet count ≥100×10³/μL.
  • Hemoglobin ≥9.0 g/dL.
  • Creatinine: serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance >50 mL/min (calculated using the Cockcroft-Gault formula).
  • Creatinine clearance for females = [140 - age (years)] × weight (kg) × 0.85 ÷ [72 × serum creatinine (mg/dL)].
  • Creatinine clearance for males = [140 - age (years)] × weight (kg) × 1.00 ÷ [72 × serum creatinine (mg/dL)].
  • Aspartate aminotransferase (AST) ≤3 × ULN, alanine aminotransferase (ALT) ≤3 × ULN, total bilirubin ≤1.5 × ULN.
  • No psychiatric/psychological disorders affecting social functioning.
  • Women of childbearing potential must have a negative serum pregnancy test (blood HCG) within 1 week before enrollment.
  • Women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use appropriate contraceptive methods.

Who cannot join

  • Multifocal cancer, or concomitant other malignant tumors.
  • Received any anti-tumor therapy for other malignant tumors within the past 5 years.
  • Underwent major surgery recently (within 6 months).
  • Presence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
  • Any uncontrolled, severe comorbid diseases.
  • Allergy to any component of the study medication.
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  • Life expectancy less than 5 years for any reason.
  • Planning to undergo or previously underwent organ/bone marrow transplantation.
  • Received immunosuppressive agents or glucocorticoid therapy aimed at suppressing immune responses within 1 month before enrollment.
  • For patients with a history of central nervous system diseases, the investigator will determine whether their current condition allows them to provide informed consent or comply with the study procedures, and subsequently decide whether they can be enrolled.
  • Other diseases or conditions that may prevent completion of the study treatment (e.g., alcoholism, drug addiction, etc.).
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yingchi Yang, M.D. contact

+86 15810152032

yangyingchi@ccmu.edu.cn

Kai Pang, M.D. contact

+86 18811792819

pk2wys@foxmail.com

China1 site

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Kai Pang, M.D., +86 18811792819, pk2wys@foxmail.com

Other trials in China

About this study

Official title: A Prospective, Phase II, Single-Arm Study on the Efficacy and Safety of Neoadjuvant Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer

The goal of this clinical trial is to test a new combination treatment for locally advanced rectal cancer (cancer in the lower or middle part of the rectum that has not spread to distant organs). The study aims to increase the chance of making the tumor disappear completely (called "complete response") and improve the quality of life by increasing the rate of anal sphincter preservation (avoiding permanent colostomy bags).

The main questions it aims to answer are:

Read more

Does the combination of short-course radiation therapy, two types of immunotherapy drugs (Qibeian and Aike), and chemotherapy (XELOX) increase the complete response rate to over 50%? Is this combination treatment safe, and what are the side effects? Can this treatment help more patients keep their anal function and avoid permanent stomas?

This is a single-arm study, meaning all participants will receive the experimental treatment (there is no placebo or control group).

Participants will:

Receive short-course radiation therapy (25 Gy total, given once daily for 5 consecutive days). The radiation will target only the tumor and visible lymph nodes, intentionally avoiding unaffected lymph node areas to protect the immune system.

Receive Qibei'an (a dual immunotherapy drug targeting both PD-1 and CTLA-4) once, 2 days after completing radiation.

Receive Camrelizumab (a PD-1 immunotherapy drug) three times, combined with XELOX chemotherapy.

Receive XELOX chemotherapy (Oxaliplatin ivgtt on Day 1, plus Capecitabine pills taken twice daily for 14 days, for each cycle) for up to 3 cycles.

Undergo detailed assessments after treatment, including MRI scans, colonoscopy with biopsies, and blood tests (including ctDNA tests), to determine if the tumor has disappeared or if surgery is needed.

Attend regular follow-up visits for up to 5 years after treatment (or surgery) to monitor for recurrence and assess quality of life.

The study will enroll approximately 19 patients at Beijing Friendship Hospital, Capital Medical University. An independent safety monitoring board will regularly review the data to ensure participant safety.

Being tested
Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy
Keywords
locally advanced rectal cancer, short-course radiotherapy, anti-PD1, anti-CTLA4, complete response
Medical subject headings
Rectal Neoplasms, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-Course Radiotherapy Combined with Chemotherapy and ImmunotherapyCombination product

    ● Radiotherapy: Total dose of 25 Gy delivered in 5 fractions, 5 Gy per fraction, over a total course of 5 days (Target area: Only the gross rectal tumor and radiologically suspected metastatic positive lymph nodes, without irradiation of additional lymphatic drainage areas).

    • Qibei'an (Iparolizumab-tovorilimab Injection): 5 mg/kg intravenous drip, administered once 2 days after radiotherapy completion.
    • Camrelizumab: 200 mg intravenous drip, administered sequentially 3 times after Qibei'an, each in combination with XELOX chemotherapy.
    • XELOX Chemotherapy:

    Oxaliplatin 130 mg/m2 intravenous drip, Day 1; Capecitabine 1000 mg/m2 orally twice daily, Day 1 to Day 14.

Study groups in NCT07397442
Study groupRoleWhat they receive
Short-course radiotherapy plus chemo-immunotherapyExperimentalNot described
Receives: Combination Product: Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Including both clinical and pathological complete response

    Measured: Approximately 4 months after treatment starts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion28 Feb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397442
Sponsor's protocol ID
2026-P2-013-01
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang Y, Pang K, Lin G, Liu X, Gao J, Zhou J, Xu L, Gao Z, Wu Y, Li A, Han J, Wu G, Wang X, Li F, Ye Y, Zhang J, Chen G, Wang H, Kong Y, Wu A, Xiao Y, Yao H, Zhang Z. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial. Nat Med. 2025 Feb;31(2):449-456. doi: 10.1038/s41591-024-03360-5. Epub 2025 Jan 6.

    PubMed 39762418

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy in people with Rectal Cancer, Adenocarcinoma and Rectal Cancer Stage II, run by Beijing Friendship Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yingchi Yang, M.D. (+86 15810152032, yangyingchi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: Approximately 4 months after treatment starts). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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