AzTrials
AzTrials

Rectal CancerPhase 2NCT06304545

Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab

A Phase 2 study testing Camrelizumab, Chemotherapy and Radiotherapy in people with Rectal Cancer, run by Harbin Medical University.

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
Search all trials

Trial summary

This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation. 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?
Camrelizumab, Chemotherapy and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
15 Mar 2024to 15 Mar 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

  • Age: 18 to 75 years old, male or female,
  • Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria),
  • Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (<5 cm from anal verge; T2N0M0),
  • Expected survival > 3 months,
  • ECOG PS score: 0-1,
  • No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed,
Show all 9Show fewer
  • No previous radiotherapy or immune checkpoint inhibitor treatment for rectal cancer,
  • Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during screening):
  • 1)Absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 80 x 10^9/L; hemoglobin ≥ 8.5 g/dL, 2)Thyroid-stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled), 3)Bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN, 4) Serum creatinine ≤1.5 times ULN, 9. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose, 10. Subjects voluntarily enrolled in the study and signed an informed consent form.

Who cannot join

  • Previous pelvic or abdominal radiotherapy,
  • Tumours that are expected to be unresectable after neoadjuvant therapy,
  • Pregnant or lactating women, or those of childbearing potential who refuse to use contraception,
  • History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled,
  • Ineffectively controlled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction,
  • Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function,
Show all 14Show fewer
  • Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment,
  • Congestive heart failure, difficult-to-control cardiac arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient is chaemic attack, severe hypertension difficult to control with medication, or other patients who cannot tolerate the procedure,
  • Severe active infections requiring intravenous antibiotic treatment occurring during the screening period,
  • Allergy to the test drug,
  • Have received or will receive a live vaccine within 30 days prior to camrelizumab administration,
  • Known history of HIV infection or active hepatitis B or C,
  • Patients who are unable to comply with the trial protocol or are unable to cooperate with follow-up visits,
  • Those who in the opinion of the investigator are not suitable for participation in this trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chunbo Zhao, MD contact

+86-13644640662

chunbozhao@hrbmu.edu.cn

About this study

Official title: Long-course Concurrent Chemoradiotherapy Combined With Camrelizumab in the Neoadjuvant Treatment of Locally Advanced/Low Anus-preserving Rectal Cancer: a Phase II Single-arm Study.

This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation.

Read the detailed description

This study plans to recruit 48 patients with locally advanced/low anal preservation requiring rectal cancer. The study aims to observe and evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab.

Conditions
Rectal Cancer
Being tested
Camrelizumab, Chemotherapy, Radiotherapy
Keywords
Camrelizumab, Long-term concurrent chemoradiotherapy, Neoadjuvant treatment, Locally advanced/low cancer requiring anus preservation
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

    Camrelizumab IV 200mg

  • ChemotherapyDrug

    Also called Capecitabine or combined oxaliplatin

    Capecitabine PO oxaliplatin IV

  • RadiotherapyRadiation

    Also called Long-term concurrent chemoradiotherapy

    Radiotherapy 50Gy /45Gy /25 fractions

Study groups in NCT06304545
Study groupRoleWhat they receive
Chemoradiotherapy combined with immunotherapy for early rectal cancer.ExperimentalRadiotherapy and Chemotherapy combined with Camrelizumab
Receives: Drug: Camrelizumab; Drug: Chemotherapy; Radiation: Radiotherapy

What is being measured

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

  1. Pathological Complete Response rate

    After neoadjuvant therapy and surgery, postoperative specimens showed no residual surviving tumor cells in the tumor bed (%RVT=0).

    Measured: up to 24 months

Secondary outcomes (7)

  1. Objective Response Rate

    Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

    Measured: up to 24 months

  2. Disease Control Rate

    Determined using RECIST v1.1 criteria.

    Measured: up to 24 months

  3. Anal preservation rate

    Proportion of patients with low rectal cancer who retain their anus after surgery.

    Measured: up to 24 months

  4. Disease-free Survival

    The time from surgical resection to the first tumor recurrence and metastasis, or the patient's death due to any reason.

    Measured: up to 24 months

  5. Overall Survival

    Defined as the time from randomizstion to death from any cause.

    Measured: up to 36 months

  6. AEs

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    Measured: up to 24 months

  7. 3-years Overall Survival rate

    Proportion of death from randomization to 3 years of treatment.

    Measured: 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.

  1. First posted12 Mar 2024
  2. Study start15 Mar 2024 (estimated)
  3. Primary completion16 Aug 2026 (estimated)
  4. Study completion15 Mar 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304545
Sponsor's protocol ID
SHR-1210-HLJ-081
Status last verified
Mar 2024
First submitted
1 Mar 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Chemotherapy and Radiotherapy in people with Rectal Cancer, run by Harbin Medical 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 9 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 12 Mar 2024. 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?

Contact Chunbo Zhao, MD (+86-13644640662, chunbozhao@hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response rate (time frame: up to 24 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 NCT06304545.

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 12 Mar 2024.

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