Rectal CancerPhase 3NCT04928807

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

A Phase 3 study testing Short course radiotherapy sequential camrelizumab and chemotherapy in people with Rectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rectal Cancer
What is being tested?: Short course radiotherapy sequential camrelizumab and chemotherapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 231 participants
Where: 1 siteChina
Study dates: 20 Jul 2021to 20 Mar 2028
Phase: Phase 3
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

Patients or their family members agree to participate in the study and sign the informed consent form;
Age 18-75 years, male or female;
Histologically confirmed T3-44 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging (8th Edition, 2017);
inferior margin ≤ 10 cm from the anal verge;
It is expected to reach R0;
ECOG performance status score is 0-1;

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Swallowing pills normally;
Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;
Surgical treatment is planned after neoadjuvant treatment;
There was no operative contraindication;
Laboratory tests were required to meet the following requirements:
white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
Males or females with reproductive ability who are willing to use contraception in the trial;

Who cannot join

Documented history of allergy to study drugs, including any component of Camrelizumab, capecitabine, irinotecan, oxaliplatin and other platinum drugs;
Have received or are receiving any of the following treatments:
Any radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Received live attenuated vaccine within 4 weeks before the first use of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
Any active autoimmune disease or history of autoimmune disease;
Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
There are clinical symptoms or diseases of heart that are not well controlled;

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Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within one year before enrollment, or with a history of active pulmonary tuberculosis infection more than one year ago but without regular treatment;
The presence of active hepatitis B (HBV DNA > 2000 IU/mL or 104 copies/mL) was positive for hepatitis C (hepatitis C antibody) and HCV RNA was higher than the lower limit of analytical method;
Female subject who is pregnant or breastfeeding;
Patients who are not suitable for participation in clinical trials in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

China1 site

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer

Read the detailed description

Patients with locally advanced rectal cancer (T3-4/N+) were randomly assigned to experimental group A or control group B according to the ratio of 1:1,who will receive preoperative neoadjuvant therapy, and the Primary endpoint of the study is Pathological complete response rate(PCR ) assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)

Conditions: Rectal Cancer
Being tested: Short course radiotherapy sequential camrelizumab and chemotherapy
Medical subject headings: Rectal Neoplasms

What participants receive

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

Short course radiotherapy sequential camrelizumab and chemotherapyCombination product
Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation

Study groups in NCT04928807
Study group	Role	What they receive
Short course radiotherapy sequential camrelizumab and chemotherapy	Experimental	Radiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX and camrelizumab, for 2 cycles. The patients were operated within 10 weeks after the last radiotherapy, and the surgical method is total mesorectal excision. Postoperative adjuvant therapy will be started 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX + camrelizumab) for 6 cycles Receives: Combination Product: Short course radiotherapy sequential camrelizumab and chemotherapy
Long term concurrent chemoradiotherapy and sequential chemotherapy	Active comparator	The patients received neoadjuvant therapy of CAPOX 2 weeks after long-term concurrent chemoradiotherapy (28*1.8Gy, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week). The patients were operated within 10 weeks after the last radiotherapy. Adjuvant therapy should begin within 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX) for 6 cycles Receives: Combination Product: Short course radiotherapy sequential camrelizumab and chemotherapy

What is being measured

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

pathological complete response (pCR) rate
Pathological complete response rate (PCR) assessed by the blind Independent Review Committee, defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
Measured: an expected average of 5 months

Secondary outcomes (5)

Event-free survival
Measured: an expected average of 5 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
R0 resection rate
The rate of negative margin microscopically
Measured: an expected average of 2 years
Disease-Free Survival
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first
Measured: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years

Timeline

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

20 Jul 202120 Mar 2028

First posted16 Jun 2021
Study start20 Jul 2021
Primary completion1 Mar 2023
Study completion20 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Rectal CancerStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04928807
Sponsor's protocol ID: MA-CRC-Ⅲ-006
Status last verified: Feb 2026
First submitted: 14 Jun 2021
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tao K, Lin Z, Zhang P, Chi P, Xiao Y, Hou Z, Xu X, Zhang A, Qiu X, Wu J, Yuan Y, Wang Z, Qu X, Li X, Nie X, Yang M, Cai K, Wang Z, Zhang W, Huang Y, Sun Z, Zheng R, Zhao F, Han C, Zhang T. Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy versus standard of care for locally advanced rectal cancer (UNION): a prespecified interim analysis of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2026 Nov;27(11):1437-1449. doi: 10.1016/S1470-2045(26)00446-8. Epub 2026 Oct 25.
PubMed 42927765
You Q, Jin M, Zhou B, Huang C, Lin Z, Hu J, Xue J, Chen X, Xiao Y, Li R, Zong Y, Wu M, Zhang T, Liu H. Gut microbiome components predict response to neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): a prospective study. Front Pharmacol. 2026 May 29;17:1829108. doi: 10.3389/fphar.2026.1829108. eCollection 2026.
PubMed 42292847
Zhang F, Yu D, Yang J, Zhai M, Li L, Zhao L, Wang J, Zhang T, Lin Z. Pretreatment high cholesterol and low neutrophils predict complete pathological response after neoadjuvant short-course radiotherapy followed by chemotherapy and immunotherapy in locally advanced rectal cancer. Oncol Lett. 2023 Jun 7;26(1):319. doi: 10.3892/ol.2023.13905. eCollection 2023 Jul.
PubMed 37332340

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT04928807
Acronym / sponsor ID: MA-CRC-Ⅲ-006
Conditions: Rectal Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 231 participants (actual)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Study start: 20 Jul 2021 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 20 Mar 2028 (estimated)
First posted: 16 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Short course radiotherapy sequential camrelizumab and chemotherapy	Experimental	Combination Product: Short course radiotherapy sequential camrelizumab and chemotherapyRadiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX and camrelizumab, for 2 cycles. The patients were operated within 10 weeks after the last radiotherapy, and the surgical method is total mesorectal excision. Postoperative adjuvant therapy will be started 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX + camrelizumab) for 6 cycles
Long term concurrent chemoradiotherapy and sequential chemotherapy	Active comparator	Combination Product: Short course radiotherapy sequential camrelizumab and chemotherapyThe patients received neoadjuvant therapy of CAPOX 2 weeks after long-term concurrent chemoradiotherapy (28*1.8Gy, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week). The patients were operated within 10 weeks after the last radiotherapy. Adjuvant therapy should begin within 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX) for 6 cycles

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Patients or their family members agree to participate in the study and sign the informed consent form;
Age 18-75 years, male or female;
Histologically confirmed T3-44 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging (8th Edition, 2017);
inferior margin ≤ 10 cm from the anal verge;
It is expected to reach R0;

Key exclusion criteria (11 listed)

Documented history of allergy to study drugs, including any component of Camrelizumab, capecitabine, irinotecan, oxaliplatin and other platinum drugs;
Have received or are receiving any of the following treatments:
Any radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Received live attenuated vaccine within 4 weeks before the first use of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
Any active autoimmune disease or history of autoimmune disease;
Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Short course radiotherapy sequential camrelizumab and chemotherapyShort course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation	Combination product	Long term concurrent chemoradiotherapy and sequential chemotherapy, Short course radiotherapy sequential camrelizumab and chemotherapy

Primary outcome

pathological complete response (pCR) rate
Time frame: an expected average of 5 months
Pathological complete response rate (PCR) assessed by the blind Independent Review Committee, defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)

5 secondary outcomes

Event-free survival
Time frame: an expected average of 5 years
Overall Survival
Time frame: an expected average of 5 years
R0 resection rate
Time frame: an expected average of 2 years
Disease-Free Survival
Time frame: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Derived from this study: PubMed 42927765Tao K, Lin Z, Zhang P, Chi P, Xiao Y, Hou Z, Xu X, Zhang A, Qiu X, Wu J, Yuan Y, Wang Z, Qu X, Li X, Nie X, Yang M, Cai K, Wang Z, Zhang W, Huang Y, Sun Z, Zheng R, Zhao F, Han C, Zhang T. Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy versus standard of care for locally advanced rectal cancer (UNION): a prespecified interim analysis of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2026 Nov;27(11):1437-1449. doi: 10.1016/S1470-2045(26)00446-8. Epub 2026 Oct 25.
Derived from this study: PubMed 42292847You Q, Jin M, Zhou B, Huang C, Lin Z, Hu J, Xue J, Chen X, Xiao Y, Li R, Zong Y, Wu M, Zhang T, Liu H. Gut microbiome components predict response to neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): a prospective study. Front Pharmacol. 2026 May 29;17:1829108. doi: 10.3389/fphar.2026.1829108. eCollection 2026.
Derived from this study: PubMed 37332340Zhang F, Yu D, Yang J, Zhai M, Li L, Zhao L, Wang J, Zhang T, Lin Z. Pretreatment high cholesterol and low neutrophils predict complete pathological response after neoadjuvant short-course radiotherapy followed by chemotherapy and immunotherapy in locally advanced rectal cancer. Oncol Lett. 2023 Jun 7;26(1):319. doi: 10.3892/ol.2023.13905. eCollection 2023 Jul.

Related trials for Rectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tao Zhang, MD principal investigator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete response (pCR) rate (time frame: an expected average of 5 months). 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 NCT04928807, which also lists 3 linked publications.

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 27 Feb 2026.