Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Immunotherapy combo shows promise in rectal cancer after standard treatment

NCT ID NCT05009069

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
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether adding two immunotherapy drugs (atezolizumab and tiragolumab) after standard chemoradiation can help eliminate tumors in people with locally advanced rectal cancer. About 58 participants will receive either the drug combination or atezolizumab alone before surgery. The main goal is to see if the cancer completely disappears by the time of surgery.

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

58 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the rectum * Resectable locally advanced rectal cancer, with clinical stage as cT3N+M0 or cT4NanyM0 per American Joint Committee on Cancer (AJCC)/ International Union Against Cancer (UICC) 8th edition * The inferior margin of the tumor ≤10cm from the anal verge * No prior anti-cancer treatment for rectal cancer * Availability of a representative tumor specimen that is suitable for pathological evaluation and biomarker expression analysis * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1 * At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RESIST) v1.1 * Adequate hematologic and end-organ function * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen * Negative HIV test at screening * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs for at least 5 months after the final dose of atezolizumab and for 90 days after the final dose of tiragolumab, for 6 months after the final dose of capecitabine, for 6 months after the final dose of 5-FU * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and agreement to refrain from donating sperm for at least 90 days after the final dose of tiragolumab, 3 months after final dose of capecitabine, for 6 months after the final dose of 5-FU. Exclusion Criteria: * Evidence of metastatic disease * Histology consistent with small cell carcinoma, squamous carcinoma, or mixed carcinoma * Presence of synchronous colorectal cancer * Presence of obstruction or imminent obstruction * Clinical symptoms or radiological suspicion of bowel perforation * Not eligible for long-course radiotherapy * History of malignancies other than rectal cancer within 3 years prior to screening with the exception of those with a negligible risk of metastasis or death * Active or history of autoimmune disease or immune deficiency * Significant cardiovascular disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Severe chronic or active infection within 4 weeks prior to initiation of study treatment * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled or symptomatic hypercalcemia * Uncontrolled diabetes or Grade ≥ 2 abnormalities in potassium, sodium, despite standard medical management within 14 days prior to initiation of study treatment * Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies * Treatment with systemic immunostimulatory agents * Treatment with systemic immunosuppressive medication * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment * Major surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study treatment * Any other disease, medical condition or abnormality, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination finding, clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications * Treatment with any other investigational agent with therapeutic intent within 28 days prior to study treatment initiation * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * History of allergic reactions to chemotherapy drugs (5-FU and capecitabine) * Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in participants selected to receive capecitabine * Pregnant or breastfeeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • First Hospital of China Medical University

    Shenyang, 110001, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

More trials for these conditions

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