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Rectal CancerPhase 3OPLARNCT07070622

Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)

A Phase 3 study testing patients were assigned to receive TNT or iTNT management in people with Rectal Cancer, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer
What is being tested?
patients were assigned to receive TNT or iTNT management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteChina
Study dates
1 Nov 2024to 31 Dec 2029
Phase
Phase 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-80 years old; Gender is not limited;
  • rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;
  • The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The distance between the lower edge of the tumor and the anal verge was ≤5cm measured by digital rectal examination or MRI; ② Clinical stage cT1-3abN0-1M0 (if cT1N0, patients suitable for endoscopic resection should be excluded); ③MRF (-) (> 1mm), EMVI (±); ④ Lateral lymph nodes were negative and less than 7mm; ⑤ tumor diameter ≤5cm; ⑥ tumor circumference ≤2/3.
  • ECOG score: 0-1;
  • Patients with primary rectal cancer did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment;
  • Normal main organ function, which met the following characteristics: ① Blood routine examination criteria: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophil ≥ 1.5×109/L, PLT≥ 100×109/L; ② Biochemical examination should meet the following criteria: Crea and BIL ≤ 1.0 times the upper limit of normal value (ULN), ALT and AST≤ 2.5 times the upper limit of normal value (ULN), alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤1.5×UNL.
  • No history of allergy to 5-Fu or platinum drugs; Women of childbearing age were required to have a negative pregnancy test (serum or urine) 7 days before enrollment and to be willing to use an appropriate method of contraception during the trial and for 8 weeks after the last dose. For men, surgical sterilization or consent to use an appropriate method of contraception for the duration of the trial or for 8 weeks after the last dose;
  • The subjects voluntarily joined the study, signed the informed consent form, with good compliance, and cooperated with follow-up.

Who cannot join

  • patients with lynch syndrome;
  • Distant metastasis was not considered at initial diagnosis but proved during treatment;
  • previous or concurrent history of other malignant tumors (including synchronous colon cancer), except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • patients who had received pelvic radiotherapy;
  • pregnant or lactating women with fertility needs; Male patients with fertility needs;
  • The presence of uncontrolled systemic diseases as determined by the investigator, including diabetes mellitus, hypertension, active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), and severe heart, lung, and kidney diseases; Subjects had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method).
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  • those with mental disorders;
  • Severe infection (CTCAE > 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Patients with active pulmonary inflammation on baseline chest imaging or signs and symptoms of infection requiring treatment with oral or intravenous antibiotics within 2 weeks before the first dose of study drug were excluded if prophylactic antibiotics were used.
  • patients with bleeding diathesis or coagulopathy were on thrombolytic/anticoagulant therapy; Aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
  • serious gastrointestinal diseases affecting the absorption of oral chemotherapy drugs, and a history of gastrointestinal fistula, perforation, bleeding or severe ulcer;
  • a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;
  • patients with a history of interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung disease, active pulmonary tuberculosis infection detected by medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
  • known allergic to macromolecular protein preparations, or to any component of tislelizumab, or allergic, hypersensitive, or contraindicated to etoposide or cisplatin or any component used in their preparations;
  • have received or are receiving any of the following therapies: a. Anti-pd-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; b. received any study drug within 4 weeks before the first dose of the study drug; c. subjects requiring systemic treatment with corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before the first dose of study drug, except when corticosteroids are used for local inflammation and to prevent allergy, nausea, and vomiting. Other special circumstances require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at a therapeutic dose of prednisone of more than 10mg per day were allowed. d. vaccination with an antitumor vaccine or live vaccine within 4 weeks before the first dose of study drug;
  • enrolled in an additional clinical trial within 4 weeks before initiation of treatment.

Trial locations and contacts

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

Wang Ziqiang, PhD contact

-86 18980602028

wangziqiang@scu.edu.cn

China1 site, 1 recruiting

  • West China Hospital

    Chengdu, Sichuan, 610041

    Wang Ziqiang, PhD, +86 18980602028, wangziqiang@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Planed Organ Preservation for Early- and Intermediate-risk Low Rectal Cancer With Good Response to Neoadjuvant Chemotherapy

On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.

Conditions
Rectal Cancer
Being tested
patients were assigned to receive TNT or iTNT management
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • patients were assigned to receive TNT or iTNT managementDrug

    TNT or iTNT

Study groups in NCT07070622
Study groupRoleWhat they receive
TNTExperimentalDuring concurrent radiotherapy, capecitabine (825mg/m2, bid, 5d/w) and oxaliplatin (130mg/m2, d1, q3w) were given for 2 cycles. After radiotherapy, two cycles of XELOX chemotherapy were given, with the specific doses of oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, D1-14, q3w. Intensity-modulated radiotherapy (IMRT/VMAT) was used for radiotherapy with a dose of 50-50.4Gy/25-28f, 1.8-2.0Gy/d, 5f/w.
Receives: Drug: patients were assigned to receive TNT or iTNT management
iTNTExperimentalLong-term radiotherapy concurrent with oxaliplatin/capecitabine chemotherapy + tillizumab immunotherapy, concurrent radiotherapy with capecitabine: 825mg/m2, bid, 5d/w, oxaliplatin: 130mg/m2, d1, q3w, tillizumab: 200mg, q3w, 2 cycles. After radiotherapy, two cycles of XELOX+ tislelizumab were given, with the specific doses of oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, D1-14, q3w, and tislelizumab 200mg, q3w. Intensity-modulated radiotherapy (IMRT/VMAT) was used for radiotherapy with a dose of 50-50.4Gy/25-28f, 1.8-2.0Gy/d, 5f/w.
Receives: Drug: patients were assigned to receive TNT or iTNT management

What is being measured

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

  1. organ preservation rate，OPR

    ① The number of patients with cCR or near cCR at 8 weeks after radiotherapy who chose watchful waiting and sustained cCR for 2 years;

    ② Patients were evaluated as cCR or near cCR at 8 weeks after the end of radiotherapy, entered watchful waiting, and finally selected local resection, and there was no recurrence within 2 years after local resection, and no additional salvage surgery.

    Measured: no recurrence within 2 years

Secondary outcomes (2)

  1. DFS

    disease free survival

    Measured: 3 years

  2. OS

    overall survival

    Measured: 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 posted17 Jul 2025
  2. Study start1 Nov 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070622
Sponsor's protocol ID
OPLAR
Acronym
OPLAR
Status last verified
Jul 2025
First submitted
8 Jul 2025
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing patients were assigned to receive TNT or iTNT management in people with Rectal Cancer, run by West China 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 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?

Contact Wang Ziqiang, PhD (-86 18980602028, wangziqiang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

organ preservation rate，OPR (time frame: no recurrence within 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 NCT07070622.

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 17 Jul 2025.

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