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MSS Locally Advanced Rectal AdenocarcinomaPhase 2NCT05216653

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)

A Phase 2 study testing Envafolimab, Oxaliplatin and Capecitabine in people with MSS Locally Advanced Rectal Adenocarcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Envafolimab, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
7 Apr 2022to 5 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patients who are willing to receive neoadjuvant therapy.
  • ≧18 years old.
  • Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 12 cm from the anus.
  • Histologically diagnosed as rectal adenocarcinoma.
  • The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were cT2-4a N+, cT3/T4a N0.
  • MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
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  • The patient has good compliance and can come to the hospital for re-examination as required.
  • ECOG Scale of Performance Status score 0-1 point.
  • Have not received anti-tumor and immunotherapy before enrollment.
  • Laboratory inspections must meet the following standards:
  • White blood cell count>3.5×109/L, absolute value of neutrophils>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L;
  • INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal;
  • Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal;
  • 24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal.
  • Voluntarily participate in this study and sign the informed consent.

Who cannot join

  • History of other malignant diseases in the past 5 years.
  • Patients with metastases from other sites (stage IV patients).
  • Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
  • Known allergic to oxaliplatin, capecitabine, PD-L1 monoclonal antibody and other drugs.
  • Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
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  • dMMR or MSI-H patients.
  • The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.
  • The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.
  • Active autoimmune disease that may worsen while receiving immunostimulants.
  • Known history of positive HIV test or known acquired immunodeficiency syndrome.
  • Patients who are using immunosuppressive agents, except for the following conditions:
  • Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections);
  • Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent;
  • Steroids used to prevent allergic reactions (eg, before CT scan).
  • Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening
  • Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.
  • Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
  • Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

Other trials in China

About this study

Official title: Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM): an Open Label, Prospective, Single Arm Clinical Trial

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Being tested
Envafolimab, Oxaliplatin, Capecitabine, Short-course Radiation, TME surgery, total mesorectal excision
Keywords
Radiation, Envafolimab

What participants receive

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

  • EnvafolimabDrug

    Also called KN053

    This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).

  • OxaliplatinDrug

    130mg/m2，ivgtt，d1

  • CapecitabineDrug

    1000mg/m2，po，bid，d1-14

  • Short-course RadiationRadiation

    Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.

  • TME surgery, total mesorectal excisionProcedure or surgery

    The surgical method can choose open, laparoscopic or robotic according to the specific condition of the patient.

Study groups in NCT05216653
Study groupRoleWhat they receive
Preoperative Short-course Radiation followed by Envafolimab plus CAPEOXExperimentalThe enrolled patients with MSS-type advanced middle-low rectal cancer will receive a combined regimen of neoadjuvant chemoradiotherapy combined with immunotherapy and total mesorectal excision (TME surgery). 1. Radiotherapy uses a short-range mode, irradiating the primary tumor and high-risk areas with dose of 25 Gy. 2. After radiotherapy, PD-L1 antibody (150mg/week, subcutaneous injection × 6 weeks) immunotherapy combined with two courses of CAPEOX chemotherapy was performed. 3. Two weeks after the end of the combined treatment plan in step 2), TME surgery is performed.
Receives: Drug: Envafolimab; Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Short-course Radiation; Procedure: TME surgery, total mesorectal excision

What is being measured

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

  1. The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then Envafolimab Plus CAPEOX

    pCR was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0).

    Measured: Up to 10 weeks (once surgery is done)

Secondary outcomes (6)

  1. Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by AJCC/CAP TRG system

    Tumor Regression Grade（TRG）will be done via pathologic assessment on the surgical specimen with AJCC/CAP TRG system

    Measured: Up to 10 weeks (once surgery is done)

  2. The proportion of participants who remain survival at 3 years

    Defined as the percentage of patients alive after 3-year follow-up

    Measured: Up to 3 years

  3. The proportion of participants who remain progression free at 3 years

    Defined as the percentage of patients without disease recurrence or progression after 3-year follow-up

    Measured: Up to 3 years

  4. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0

    Treatment- related adverse events are assessed by NCI-CTCAE v5.0 in each visit

    Measured: Up to 3 years

  5. Surgical Complications of total mesorectal resection procedure for patients after short-course radiation then Envafolimab Plus CAPEOX as assessed by Clavien-Dindo classification

    Surgical Complications are assessed by Clavien-Dindo classification after surgery.

    Measured: Up to 24 weeks

  6. Quality of life of the patients in a neoadjuvant setting of short-course radiation then Envafolimab Plus CAPEOX as assessed by FACT-C questionnaire

    Quality of life is measured via FACT-C questionnaire in each visit.

    Measured: Up to 3 years

Timeline

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

  1. First posted31 Jan 2022
  2. Study start7 Apr 2022
  3. Primary completion31 Mar 2023
  4. Study completion5 Mar 2025

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216653
Sponsor's protocol ID
20220111-8
Status last verified
Mar 2025
First submitted
14 Jan 2022
Last updated
13 Mar 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 Envafolimab, Oxaliplatin and Capecitabine in people with MSS Locally Advanced Rectal Adenocarcinoma, run by Sir Run Run Shaw 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 15 inclusion and 19 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: finished, as of the sponsor's last update on 13 Mar 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then Envafolimab Plus CAPEOX (time frame: Up to 10 weeks (once surgery is done)). 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 NCT05216653.

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 13 Mar 2025.

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