AzTrials
AzTrials

Rectal AdenocarcinomaPhase 2NCT06919510

A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer

A Phase 2 study testing lvonescimab, CAPOX (oxaliplatin/capecitabine) and radiotherapy in people with Rectal Adenocarcinoma, run by Sun Yat-sen University.

Not yet recruiting

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer. Patients were randomly assigned to experimental group A or control group B according to a 1:1 ratio. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Adenocarcinoma
What is being tested?
lvonescimab, CAPOX (oxaliplatin/capecitabine) and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 1 Dec 2028
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 between 18 and 75 years;
  • ECOG perfommance status of 0 or 1;
  • Life expectancy: more than 2 years;
  • Histologically proven rectal adenocarcinoma;
  • Tumor biopsy immunohistochemistry proven pMMR, positive for four proteins, MLH1, MSH2, MSH6 and PMS2, or MSS determined by gene testing;
  • According to the 8th Edition of the AJCC Staging Manual, clinical stage cT3-4NanyM0 or cTxN+M0 of II-III rectal cancer was determined by Magnetic resonance imaging (MRI)±transrectal ultrasonography/ ultrasound endoscopy. Lower edge of the tumor was ≤ 12 cm from the anal verge;
Show all 10Show fewer
  • Eligible for R0 surgery;
  • No prior anti-tumor treatment for rectal cancer,including radiotherapy,chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc;
  • Adequate organ function;
  • Males or females with reproductive ability who are willing to use contraception in the trial;

Who cannot join

  • Any distant metastasis or inoperable disease, regardless clinical stage;
  • Previous (within 5 years) or concurrent other malignant tumors, excluding those that have been cured;
  • Current presence of gastric intestine obstruction, bleeding or perforation which need emergency surgery;
  • Multiple primary rectal cancers;
  • Previous pelvic or abdominal radiotherapy;
  • Difficulty swallowing;
Show all 13Show fewer
  • Current presence of uncontrolled combined disease;
  • Active clinical infections;
  • History of severe bleeding tendency or coagulation dysfunction;
  • Presence or history of immunodeficiency; positive for HIV antibodies, current long-term use of systemic corticosteroids or other immunosuppressants;
  • Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection;
  • Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study;
  • Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival;

About this study

Official title: A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Lvonescimab and Chemotherapy Versus Neoadjuvant Short-course Radiotherapy Followed by Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer

The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer. Patients were randomly assigned to experimental group A or control group B according to a 1:1 ratio. In group A, patients will receive neoadjuvant short-course radiotherapy followed by ivonescimab and chemotherapy. In group B, patients will receive neoadjuvant short-course radiotherapy followed by chemotherapy. After neoadjuvant treatment, the patients and investigator could choose one of the following treatments:(1) Surgery. The patients will receive surgery within 4-8 weeks after the last dose of capecitabine, and the surgical method is selected by the investigator, (2) Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy).

Being tested
lvonescimab, CAPOX (oxaliplatin/capecitabine), radiotherapy, Surgery or watch&wait
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • lvonescimabDrug

    lvonescimab, DS1, D1,q3w, intravenous infusion

  • CAPOX (oxaliplatin/capecitabine)Drug

    Oxaliplatin 130 mg / m2, D1, intravenous infusion, q3w, Capecitabine 1000 mg / m2,twice a day, oral,1-14 days, then rest for 7 days, q3w.

  • radiotherapyRadiation

    5* 5Gy, once a day, 5Gy each time, for 5 days

  • Surgery or watch&waitProcedure or surgery

    The surgical method is selected by the investigator. Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy)

Study groups in NCT06919510
Study groupRoleWhat they receive
Group A (Short-course radiotherapy followed by ivonescimab and chemotherapy)ExperimentalSubjects will receive short-course radiotherapy of 25Gy/5 fractions, followed by neoadjuvant chemotherapy of CAPOX and ivonescimab. After neoadjuvant treatment, the patients and investigator could choose one of the following treatments:(1) Surgery. The patients will receive surgery within 4-8 weeks after the last dose of capecitabine, and the surgical method is selected by the investigator: (2) Watch and Wait(only for patients with clinical complete response after neoadjuvant therapy).
Receives: Drug: lvonescimab; Drug: CAPOX (oxaliplatin/capecitabine); Radiation: radiotherapy; Procedure: Surgery or watch&wait
Group B (Short-course radiotherapy followed by chemotherapy)Active comparatorSubjects will receive short-course radiotherapy of 25Gy/5 Fraction, followed by neoadjuvant chemotherapy of CAPOX .After neoadiuvant treatment, the patients and investigator could choose one of the following treatments:(1) Surgery. The patients will receive surgery within 4-8 weeks after the last dose of capecitabine, and the surgical method is selected by the investigator; (2) Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy).
Receives: Drug: CAPOX (oxaliplatin/capecitabine); Radiation: radiotherapy; Procedure: Surgery or watch&wait

What is being measured

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

  1. Adverse events

    Adverse events and surgical safety

    Measured: Through study completion, an average of 6 month

  2. Complete response rate

    The proportion of CR cases (pCR for those who underwent surgery and cCR for those who didn't receive surgery)

    Measured: 4 weeks after curative surgery for pCR; 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine) for cCR

  3. Clinical complete response rate

    The proportion of clinical complete response cases.

    Measured: 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine)

Secondary outcomes (7)

  1. Pathologic complete response

    The proportion of pathologic complete response cases for those who underwent surgery

    Measured: 4 weeks after surgery

  2. TRG

    Tumor regression grade according to AJCC TRG grading system

    Measured: 4 weeks after surgery

  3. R0 resection rate

    R0 resection rate

    Measured: 4 weeks after surgery

  4. Local recurrence

    Local recurrence

    Measured: 3 years after Randomization

  5. Distant metastasis

    Distant metastasis

    Measured: 3 years after Randomization

  6. OS

    Overall survial

    Measured: 3 years after Randomization

  7. EFS

    Event free of survival

    Measured: 3 years after Randomization

Timeline

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

  1. First posted9 Apr 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2028 (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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919510
Sponsor's protocol ID
AK112-IIT-016
Status last verified
Apr 2025
First submitted
2 Apr 2025
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lvonescimab, CAPOX (oxaliplatin/capecitabine) and radiotherapy in people with Rectal Adenocarcinoma, run by Sun Yat-sen University.

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 10 inclusion and 13 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 9 Apr 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?

Adverse events (time frame: Through study completion, an average of 6 month). The study lists 3 primary outcomes in all. 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 NCT06919510.

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 9 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in