Unresectable Metastatic Rectal CancerPhase 2Union-mRCNCT07059949

Short Course Radiotherapy Followed by CAPOX and Carrilizumab and Bevacizumab or Cetuximab for the Initial Treatment of Unresectable Metastatic Rectal Cancer

A Phase 2 study testing CAPOX+ Camrelizumab+ Cetuximab and CAPOX+ Camrelizumab+ Bevacizumab in people with Unresectable Metastatic Rectal Cancer and CAPOX, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Not yet recruiting

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

Official record

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Trial summary

To evaluate the efficacy and safety of short-course radiotherapy followed by CAPOX and carrilizumab and bevacizumab or cetuximab in the initial treatment of unresectable metastatic rectal cancer Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Unresectable Metastatic Rectal Cancer, CAPOX, Combination of Radioimmunotherapy
What is being tested?: CAPOX+ Camrelizumab+ Cetuximab and CAPOX+ Camrelizumab+ Bevacizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: 30 Jun 2025to 30 Jun 2027
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

Sign a written informed consent and be able to comply with the visiting arrangements and related procedures stipulated in the programme;
Age ≥18 years old and ≤75 years old, gender is not limited;
Histologically confirmed rectal cancer with initial treatment (no surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
Radiologically confirmed unresectable metastatic rectal cancer (cTxNxM1);
Tissue samples must be provided for molecular typing (such as PD-L1, MSI, KRAS, NRAS, BRAVF, etc.), and newly acquired groups are preferred For patients who cannot provide newly obtained tissue, 5-8 paraffin sections with a thickness of 5um can be provided for archiving.
No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency;

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Baseline * (within 7 days before the first administration of the study drug) blood routine tests meet the following requirements:
Hemoglobin ≥90g/L Absolute neutrophil count (ANC) ≥1.5×109
/L Platelet count ≥100×109/L Eosinophils ≤1.5× Upper limit of normal (ULN)
Throughout the protocol, "baseline" is defined as the last available observation before the first administration of the investigational drug. Subjects must not have received blood transfusion products (including red suspension, apheresis platelets, cryoprecipitate, etc.), erythropoietin, or colony-stimulating factor support therapy within 7 days prior to blood sample collection.
Serum biochemical tests at baseline (within 7 days before the first dose) met the following requirements
Requirements:
Total bilirubin ≤1.5× Upper limit of normal (ULN) (if total bilirubin > 1.5× upper limit of normal, combined with bilirubin
≤ULN was allowed to be included in the study); Aspartate aminotransferase (AST) or Alanine aminotransferase (AST) ALT) ≤2.5× upper limit of normal value; Serum Creatinine ≤1.5×ULN or Clearance of Creatinine (CCr) ≥45mL/min were obtained by Cockcroft-Gault formula Calculate CCr (using actual body weight); Albumin ≥30g/L.
Coagulation tests at baseline (within 7 days before the first dose) meet the following requirements:
International normalizaed ratio (INR) ≤1.5×ULN (≤3× if receiving steady dose anticoagulation therapy) ULN); Partial thromboplastin time (PTT) (or activated partial plastin time (PTT)) thromboplastin time, aPTT]) ≤1.5×ULN (≤3×ULN if receiving stable dose anticoagulant therapy);
Urine routine examination at baseline (within 7 days before the first dose) meets the following requirements: urinary protein (UPRO) < 2+ or 24-hour urinary protein quantity < 1g;
At least one measurable lesion according to RECIST v1.1 (Solid tumor) criteria;
The Physical status score (ECOG PS) of the Eastern United States Tumor Consortium was 0 or 1;
Expected survival time ≥3 months.
Female subjects of childbearing age or male subjects whose partner is a female of childbearing age agree to strictly use effective contraception throughout the treatment period and for 6 months after the treatment period

Who cannot join

Previous exposure to any anti-PD-1 or anti-PD-L1 antibodies;
Women who are breastfeeding, pregnant or preparing to become pregnant;
Corticosteroid (dose equivalent to prednisone >10 mg/ day) or other immunosuppressive therapy should be administered within 2 weeks prior to study drug administration;
Active, known, or suspected autoimmune disease or previous 2-year history of the disease (vitiligo, psoriasis, alopecia, or Grave's disease that did not require systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy were eligible);
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; People with HIV, or active hepatitis B or C (active hepatitis B reference: ≥104 copies /ml of HBV DNA; Active hepatitis C reference: HCV RNA≥103 copies /ml);
Interstitial lung disease (including past and present disease), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
Allergy and multiple drug allergy;
There are serious heart, lung, liver and kidney dysfunction, such as decompensated heart, lung, kidney, liver and other major organ dysfunction, failure or poor blood sugar control, can not tolerate chemotherapy

About this study

Official title: Phase II, Single-center Study of Short-course Radiotherapy Followed by CAPOX and Carrelizumab and Bevacizumab or Cetuximab in the Treatment of Initially Unresectable Metastatic Rectal Cancer

To evaluate the efficacy and safety of short-course radiotherapy followed by CAPOX and carrilizumab and bevacizumab or cetuximab in the initial treatment of unresectable metastatic rectal cancer

Conditions: Unresectable Metastatic Rectal Cancer, CAPOX, Combination of Radioimmunotherapy
Being tested: CAPOX+ Camrelizumab+ Cetuximab, CAPOX+ Camrelizumab+ Bevacizumab

What participants receive

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

CAPOX+ Camrelizumab+ CetuximabDrug
For advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained
CAPOX+ Camrelizumab+ BevacizumabDrug
For advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained

Study groups in NCT07059949
Study group	Role	What they receive
Can't remove RAS/BRAF completely wild	Experimental	CAPOX+ Camrelizumab + Cetuximab Receives: Drug: CAPOX+ Camrelizumab+ Cetuximab
RAS/BRAF mutations cannot be resected	Experimental	CAPOX+ Camrelizumab + Bevacizumab Receives: Drug: CAPOX+ Camrelizumab+ Bevacizumab

What is being measured

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

ORR
Objective response rate
Measured: From enrollment to initial efficacy evaluation,assessed up to 6 months

Secondary outcomes (4)

PFS
Progression free survival
Measured: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 18 months
OS
Overall Survival
Measured: From enrollment to patient death,assessed up to 36 months
DCR
Disease Control Rate
Measured: Through out the study (24 months)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of SpecialInterest (AESl) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to CommonTerminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Measured: Through out the study (up to 36 months)

Timeline

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

30 Jun 202530 Jun 2027

First posted11 Jul 2025
Study start30 Jun 2025 (estimated)
Primary completion30 Jan 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unresectable Metastatic 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07059949
Sponsor's protocol ID: Union-mRC(ongoing)
Acronym: Union-mRC
Status last verified: Apr 2025
First submitted: 17 Apr 2025
Last updated: 11 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

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?

Official record

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Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma
Active, not recruitingPhase 1/2
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
BRAF NP_004324.2:p.V600E, Metastatic Colon Adenocarcinoma
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All Unresectable Metastatic Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Single-center Study of Short-course Radiotherapy Followed by CAPOX and Carrelizumab and Bevacizumab or Cetuximab in the Treatment of Initially Unresectable Metastatic Rectal Cancer
ClinicalTrials.gov ID: NCT07059949
Acronym / sponsor ID: Union-mRC / Union-mRC(ongoing)
Conditions: Unresectable Metastatic Rectal Cancer, CAPOX, Combination of Radioimmunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 30 Jun 2025 (estimated)
Primary completion: 30 Jan 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 11 Jul 2025 (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.

To evaluate the efficacy and safety of short-course radiotherapy followed by CAPOX and carrilizumab and bevacizumab or cetuximab in the initial treatment of unresectable metastatic rectal cancer

Study design

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

Arm	Type	Receives
Can't remove RAS/BRAF completely wild	Experimental	Drug: CAPOX+ Camrelizumab+ CetuximabCAPOX+ Camrelizumab + Cetuximab
RAS/BRAF mutations cannot be resected	Experimental	Drug: CAPOX+ Camrelizumab+ BevacizumabCAPOX+ Camrelizumab + Bevacizumab

Who may qualify

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

Key inclusion criteria (21 listed)

Sign a written informed consent and be able to comply with the visiting arrangements and related procedures stipulated in the programme;
Age ≥18 years old and ≤75 years old, gender is not limited;
Histologically confirmed rectal cancer with initial treatment (no surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
Radiologically confirmed unresectable metastatic rectal cancer (cTxNxM1);
Tissue samples must be provided for molecular typing (such as PD-L1, MSI, KRAS, NRAS, BRAVF, etc.), and newly acquired groups are preferred For patients who cannot provide newly obtained tissue, 5-8 paraffin sections with a thickness of 5um can be provided for archiving.

Key exclusion criteria (8 listed)

Previous exposure to any anti-PD-1 or anti-PD-L1 antibodies;
Women who are breastfeeding, pregnant or preparing to become pregnant;
Corticosteroid (dose equivalent to prednisone >10 mg/ day) or other immunosuppressive therapy should be administered within 2 weeks prior to study drug administration;
Active, known, or suspected autoimmune disease or previous 2-year history of the disease (vitiligo, psoriasis, alopecia, or Grave's disease that did not require systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy were eligible);
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; People with HIV, or active hepatitis B or C (active hepatitis B reference: ≥104 copies /ml of HBV DNA; Active hepatitis C reference: HCV RNA≥103 copies /ml);

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
CAPOX+ Camrelizumab+ CetuximabFor advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained	Drug	Can't remove RAS/BRAF completely wild
CAPOX+ Camrelizumab+ BevacizumabFor advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained	Drug	RAS/BRAF mutations cannot be resected

Primary outcome

ORR
Time frame: From enrollment to initial efficacy evaluation,assessed up to 6 months
Objective response rate

4 secondary outcomes

PFS
Time frame: From enrollment to the first appearance of disease progression or date of deathfrom any cause,whichever came first, assessed up to 18 months
OS
Time frame: From enrollment to patient death,assessed up to 36 months
DCR
Time frame: Through out the study (24 months)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of SpecialInterest (AESl) and Serious Adverse Event (SAE)
Time frame: Through out the study (up to 36 months)

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 11 Jul 2025.

Related trials for Unresectable Metastatic Rectal Cancer

Active, not recruitingPhase 1/2
LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
Metastatic Colon Adenocarcinoma, Metastatic Colorectal Carcinoma
Active, not recruitingPhase 1/2
SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial
Metastatic Colon Adenocarcinoma, Metastatic Colorectal Carcinoma
Active, not recruitingPhase 2
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma
Active, not recruitingPhase 1/2
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
BRAF NP_004324.2:p.V600E, Metastatic Colon Adenocarcinoma
RecruitingPhase 2
Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC
Colo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

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.

The record lists no contact. Use the official record to reach the sponsor.

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 21 inclusion and 8 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

ORR (time frame: From enrollment to initial efficacy evaluation,assessed up to 6 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 NCT07059949.

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 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.