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Rectal CancerPhase 2/3NCT07134218

Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer

A Phase 2/3 study testing serplulimab、bevacizumab and neoadjuvant chemoradiation therapy in people with Rectal Cancer, run by Changhai Hospital at 1 site in China.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally… 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?
serplulimab、bevacizumab and neoadjuvant chemoradiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
Oct 2025to Oct 2027
Phase
Phase 2/3
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

  • Signed written informed consent to voluntarily participate in the study;
  • Aged 18 to 75 years, inclusive, regardless of sex;
  • Histologically confirmed rectal adenocarcinoma with immunohistochemistry results showing proficient mismatch repair (pMMR) or molecular testing results indicating microsatellite stability (MSS);
  • Clinical baseline staging assessed by MRI as T3-4N0M0/TanyN+M, with negative mesorectal fascia (MRF);
  • Tumor lower margin ≤7 cm from the anal verge;
  • Surgically resectable;
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  • Capable of swallowing tablets normally;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1;
  • No prior anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, or surgery;
  • Planned to undergo surgical treatment after completion of neoadjuvant therapy;
  • No contraindications to surgery;
  • Normal function of major organs.

Who cannot join

  • History of allergy to any component of bevacizumab, serplulimab, 5-FU, or oxaliplatin.
  • Prior or ongoing treatment with any of the following:
  • Any tumor-targeted surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
  • Immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 2 weeks before the first administration of the study drug (dose > 10 mg/day prednisone or equivalent). Inhaled or topical corticosteroids and adrenal corticosteroid replacement therapy (dose > 10 mg/day prednisone or equivalent) are permitted in the absence of active autoimmune disease.
  • Live-attenuated vaccine within 4 weeks before the first administration of the study drug.
  • Major surgery or severe trauma within 4 weeks before the first administration of the study drug.
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  • Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (participants on hormone replacement therapy may be considered for inclusion). Participants with psoriasis or childhood asthma/allergy that has fully resolved and requires no intervention in adulthood may be considered for inclusion, but those requiring bronchodilator therapy are not eligible.
  • History of immunodeficiency, including HIV positivity, or other acquired or congenital immunodeficiency diseases, or history of organ transplant or allogeneic bone marrow transplant.
  • Uncontrolled cardiac symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that are not controlled or remain poorly controlled after clinical intervention.
  • Severe infection (CTCAE > grade 2) within 4 weeks before the first administration of the study drug, such as severe pneumonia, bacteremia, or infection with complications requiring hospitalization. Baseline chest imaging showing active pulmonary inflammation, or presence of signs and symptoms of infection or need for oral or intravenous antibiotic therapy within 14 days before the first administration of the study drug (excluding prophylactic antibiotic use). History of active pulmonary tuberculosis infection identified through medical history or CT scan, or history of active pulmonary tuberculosis infection within the past year, or history of active pulmonary tuberculosis infection more than 1 year ago that was not properly treated.
  • Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay).
  • Diagnosis of other malignancies within 5 years before the first administration of the study drug, unless the malignancy has a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ, which may be considered for inclusion.
  • Pregnant or breastfeeding women.
  • Presence of other factors that, in the investigator's judgment, may lead to forced discontinuation of the study, such as other severe diseases (including psychiatric conditions) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect the participant's safety or compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Department of Colorectal Surgery in Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Wei Zhang, 021-31161613, weizhang2000cn@163.com

Other trials in China

About this study

Official title: A National Multicenter, Prospective, Randomized Controlled Study of Serplulimab Injection Combined With Bevacizumab to Improve the Complete Response Rate of Neoadjuvant Therapy for Locally Advanced Stage Intermediate and Low Rectal Cancer

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally advanced rectal cancer. The study plans to enroll a total of 200 participants (100 in the experimental arm and 100 in the control arm).

Conditions
Rectal Cancer
Being tested
serplulimab、bevacizumab, neoadjuvant chemoradiation therapy
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • serplulimab、bevacizumabDrug

    short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 2 cycles of FOLFOX + serplulimab + bevacizumab → 2 cycles of FOLFOX + serplulimab.

  • neoadjuvant chemoradiation therapyOther

    short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 4 cycles of FOLFOX alone.

Study groups in NCT07134218
Study groupRoleWhat they receive
neoadjuvant chemoradiation therapy + serplulimab + bevacizumabExperimentalNot described
Receives: Drug: serplulimab、bevacizumab
neoadjuvant chemoradiation therapyOtherNot described
Receives: Drug: serplulimab、bevacizumab; Other: neoadjuvant chemoradiation therapy

What is being measured

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

  1. The rate of cCR

    Rate of patients who achieve clinical complete response

    Measured: 2 years

Secondary outcomes (8)

  1. Major Pathological Response

    Rate of major pathological response assessed by postoperative pathology

    Measured: 2 years

  2. Objective Response Rate

    Objective response rate assessed by RECIST 1.1 criteria

    Measured: 2 years

  3. Disease-Free Survival (DFS)

    DFS was defined as the duration from the date of randomization to the date of the first recurrence (local, distant, or mixed) or death.

    Measured: 2 years

  4. Overall Survival (OS)

    Time from randomization to death due to any cause

    Measured: 2 years

  5. Organ Preservation Rate (OPR)

    Proportion of patients who achieve organ preservation by choosing a watch-and-wait strategy or local excision after attaining clinical or pathological complete response

    Measured: 2 years

  6. Neoadjuvant Rectal Score (NAR)

    Neoadjuvant rectal score assessed by postoperative pathology

    Measured: 2 years

  7. Quality of Life Score (QoL)

    Quality of life score during treatment and follow-up

    Measured: 2 years

  8. Safety and Tolerability

    Incidence of adverse events (AEs), incidence of abnormal laboratory values, and dose adjustments during treatment and follow-up

    Measured: 2 years

Timeline

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

  1. First posted21 Aug 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134218
Sponsor's protocol ID
CHOICE IV
Status last verified
Aug 2025
First submitted
14 Aug 2025
Last updated
21 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD would be available upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing serplulimab、bevacizumab and neoadjuvant chemoradiation therapy in people with Rectal Cancer, run by Changhai Hospital at 1 site 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 14 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 21 Aug 2025. 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 combined 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of cCR (time frame: 2 years). 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 NCT07134218.

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 21 Aug 2025.

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