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Rectal NeoplasmsPhase 2NCT05009069

A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer

A Phase 2 study testing Radiotherapy, Capecitabine and Fluorouracil in people with Rectal Neoplasms and Rectal Cancer, run by Hoffmann-La Roche at 5 sites 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

This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Neoplasms, Rectal Cancer
What is being tested?
Radiotherapy, Capecitabine and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
5 sitesChina
Study dates
18 Mar 2022to 10 Nov 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • First Hospital of China Medical University

    Shenyang, 110001

Other trials in China

About this study

Official title: A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm.

Being tested
Radiotherapy, Capecitabine, Fluorouracil, Atezolizumab, Tiragolumab
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • RadiotherapyRadiation

    Weeks 1-5: 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.

  • CapecitabineDrug

    Weeks 1-5: Capecitabine 825 mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy.

  • FluorouracilDrug

    Weeks 1-5: fluorouracil (5-FU) 225 mg/m^2 intravenously (IV) over 24 hours 5 days/week during radiotherapy.

  • AtezolizumabDrug

    Weeks 8, 11 and 14: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle for 3 cycles.

  • TiragolumabDrug

    Weeks 8, 11 and 14: Tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 3 cycles.

Study groups in NCT05009069
Study groupRoleWhat they receive
Atezolizumab + TiragolumabExperimentalWeeks 1-5: Radiotherapy to the pelvis on Days 1-5 every week. Chemotherapy: Capecitabine or fluorouracil (5-FU) 5 days/week during radiotherapy. Day 1 of Weeks 8, 11 and 14: Atezolizumab plus tiragolumab (Day 1 of each 21-day cycle for 3 cycles).
Receives: Radiation: Radiotherapy; Drug: Capecitabine; Drug: Fluorouracil; Drug: Atezolizumab; Drug: Tiragolumab
AtezolizumabOtherWeeks 1-5: Radiotherapy to the pelvis on Days 1-5 every week. Chemotherapy: Capecitabine or fluorouracil (5-FU) 5 days/week during radiotherapy. Day 1 of Weeks 8, 11 and 14: Atezolizumab (Day 1 of each 21-day cycle for 3 cycles).
Receives: Radiation: Radiotherapy; Drug: Capecitabine; Drug: Fluorouracil; Drug: Atezolizumab

What is being measured

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

  1. Percentage of Participants With Pathological Complete Response (pCR)

    Measured: At Week 16, Day 1

Secondary outcomes (8)

  1. Percentage of Participants With R0 Resection

    Measured: At Week 16, Day 1

  2. Objective Response Rate (ORR) Before Surgery

    Measured: At Week 16, Day 1

  3. One/Two/Three-year Relapse-free Survival (1/2/3-y RFS) Rate

    Measured: Year 1, Year 2, Year 3

  4. One/Two/Three-year Event-free Survival (1/2/3-y EFS) Rate

    Measured: Year 1, Year 2, Year 3

  5. Percentage of Participants With pCR in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression

    Measured: At Week 16, Day 1

  6. 1/2/3-y Disease-free Survival (DFS) Rate in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression

    Measured: Year 1, Year 2, Year 3

  7. 1/2/3-y EFS Rate in Subgroup Population With PD-L1/ PVR/TIGIT Positive Expression

    Measured: Year 1, Year 2, Year 3

  8. Percentage of Participants With Adverse Events

    Measured: Up to 40 months

Timeline

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

  1. First posted17 Aug 2021
  2. Study start18 Mar 2022
  3. Primary completion21 Nov 2023
  4. Study completion10 Nov 2026 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009069
Sponsor's protocol ID
ML43050
Status last verified
Jul 2026
First submitted
10 Aug 2021
Last updated
28 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Tang W, Wu A, Lan P, Ding K, Wang Z, Wang J, Chen N, Wu X, Jiao Y, Liu F, Tong L, Shi Y, Xu J. Randomized Parallel-Group Phase II Study (NEOTERIC) of Atezolizumab With or Without Tiragolumab After Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer. J Clin Oncol. 2026 Mar;44(7):565-574. doi: 10.1200/JCO-25-01883. Epub 2026 Jan 13.

    PubMed 41529226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy, Capecitabine and Fluorouracil in people with Rectal Neoplasms and Rectal Cancer, run by Hoffmann-La Roche at 5 sites 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 12 inclusion and 27 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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?

Percentage of Participants With Pathological Complete Response (pCR) (time frame: At Week 16, Day 1). 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 NCT05009069, 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 28 Jul 2026.

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