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Stomach AdenocarcinomaPhase 2TORCH-GNCT06728657

Preoperative HFRT Verses PULSAR for Locally Advanced GEJ or Proximal Gastric Adenocarcinoma

A Phase 2 study testing HFRT targeted to the primary lesion and positive lymph nodes, PULSAR targeted to the primary lesion and positive lymph nodes and Anti-PD-1 monoclonal antibody in people with Stomach Adenocarcinoma and Gastro-esophageal Junction Cancer, run by Fudan University at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy and safety of the multimodal treatment, which includes radiotherapy, chemotherapy and anti-PD-1 immunotherapy. The trial is designed using a pick-the-winner strategy. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HFRT targeted to the primary lesion and positive lymph nodes, PULSAR targeted to the primary lesion and positive lymph nodes and Anti-PD-1 monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
1 Jul 2024to 31 Dec 2028
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed adenocarcinoma of proximal stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).
  • Potentially resectable, cT3-4aN+M0 or cT4bNanyM0.
  • Exclusion of peritoneal metastasis through laparoscopic exploration or FAPI PET/CT.
  • The status of HER2, MMR, EBER is clear.
  • Male or female. Patient age ≥ 18 years and ≤ 75 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
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  • Physical state or organ function can tolerate the planned treatment of the study protocol.
  • No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.
  • Patients agree to sign written informed consent before recruitment.

Who cannot join

  • Pregnancy or breastfeeding women.
  • History of other malignancies within 5 years.
  • Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  • Immunodeficiency disease or long-term using of immunosuppressive agents.
  • Allergic to any component of the therapy.
  • Any other condition or disease that is not suitable to take the therapy included in the protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: A Phase II Randomized Trial of Preoperative Hypofractionated Radiotherapy (HFRT) Compared to Personalized Hyperfractionated Stereotactic Adaptive Radiotherapy (PULSAR), Combined With Chemotherapy and PD-1 Monoclonal Antibody for Locally Advanced Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

The goal of this clinical trial is to evaluate the efficacy and safety of the multimodal treatment, which includes radiotherapy, chemotherapy and anti-PD-1 immunotherapy. The trial is designed using a pick-the-winner strategy.

The main questions it aims to answer are:

Read more
  1. If the multimodal treatment will improve the pCR rate.
  2. If the multimodal treatment can be performed safely.
  3. Hypofractionated radiotherapy (HFRT) or personalized hyperfractionated stereotactic adaptive radiotherapy (PULSAR), which pattern of radiotherapy can better synergize with immunotherapy.

Participants will receive HFRT or PULSAR for the primary lesion and positive lymph nodes, combined with CAPOX and anti-PD-1 immunotherapy. Then, reassessment will be performed within 4 weeks afterwards. For resectable participants, surgical resections will be performed. Postoperative treatment will be determined by the investigators. For unresectable or inoperable participants, the subsequent treatment will be determined by investigators or MDT.

Being tested
HFRT targeted to the primary lesion and positive lymph nodes, PULSAR targeted to the primary lesion and positive lymph nodes, Anti-PD-1 monoclonal antibody, Chemotherapy, R0 total/subtotal gastrectomy with D2 lymphadenectomy
Keywords
radiotherapy, PD-1 inhibitors, chemotherapy, locally advanced, gastrectomy, neoadjuvant, hypofractionated radiotherapy

What participants receive

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

  • HFRT targeted to the primary lesion and positive lymph nodesRadiation

    Hypofractionated radiotherapy (HFRT) targeted to the primary lesion and positive lymph nodes (4Gy × 6 fractions)

  • PULSAR targeted to the primary lesion and positive lymph nodesRadiation

    Irradiation targeted to the primary lesion and positive lymph nodes (6 Gy/1 fraction)

  • Anti-PD-1 monoclonal antibodyDrug

    The anti-PD-1 mAb is used on day 1 along with each cycle of chemotherapy. There are no restrictions on the choice of anti-PD-1 mAb. Patients can choose commonly used accessible monoclonal antibodies based on their personal preferences and financial status. The commonly used anti-PD-1 mAb usages are as follows: Nivolumab, 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Sintilimab, 200mg solution intravenously once daily, Q3W.

  • ChemotherapyDrug

    CAPOX: Capecitabine 1000 mg/m2 twice a day, days 1-14 and oxaliplatin 130 mg/m2, day 1, every 3 weeks

  • R0 total/subtotal gastrectomy with D2 lymphadenectomyProcedure or surgery

    For resectable participants, gastrectomy with standard D2 lymphadenectomy is commonly used. The type of gastrectomy performed depends on the location and extent of the primary lesion.

Study groups in NCT06728657
Study groupRoleWhat they receive
HFRTExperimentalParticipants will receive upfront hypofractionated radiotherapy (HFRT) of the primary lesion and positive lymph nodes (24 Gy/6 fractions). Afterwards, systemic therapy consisted of CAPOX and PD-1 antibodies will be administered every three weeks, for at least 3 cycles. Then, reassessment will be performed within 4 weeks afterwards. For resectable participants, surgical resections of primary lesion will be performed. Postoperative treatment will be determined by the investigators. For unresectable or inoperable participants, the subsequent treatment will be determined by investigators or MDT.
Receives: Radiation: HFRT targeted to the primary lesion and positive lymph nodes; Drug: Anti-PD-1 monoclonal antibody; Drug: Chemotherapy; Procedure: R0 total/subtotal gastrectomy with D2 lymphadenectomy
PULSARExperimentalParticipants will receive treatment every three weeks, for at least 3 cycles. Each cycle of treatment consists of irradiation (6 Gy/1 fraction) to the primary lesion and positive lymph nodes on day 1, and systemic therapy consisted of CAPOX and PD-1 antibodies will be administered on day 2. Then, reassessment was performed within 4 weeks afterwards. For resectable participants, surgical resections of primary lesion will be performed. Postoperative treatment will be determined by the investigators. For unresectable or inoperable participants, the subsequent treatment will be determined by investigators or MDT.
Receives: Radiation: PULSAR targeted to the primary lesion and positive lymph nodes; Drug: Anti-PD-1 monoclonal antibody; Drug: Chemotherapy; Procedure: R0 total/subtotal gastrectomy with D2 lymphadenectomy

What is being measured

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

  1. Pathological complete regression (pCR) rate

    Proportion of patients who attain pCR after preoperative treatment.

    Measured: 6 months after the enrollment of the last subject

Secondary outcomes (7)

  1. R0 resection rate

    Proportion of patients who achieve R0 resection.

    Measured: 6 months after the enrollment of the last subject

  2. Objective response rate (ORR)

    Proportion of patients with complete response (CR) or partial response (PR) to preoperative therapy. ORR will be evaluated using RESIST1.1

    Measured: 6 months after the recruitment of the last subject

  3. Event-free survival (EFS)

    EFS is defined as the time interval from enrollment to an event which includes disease progression, discontinuation of the treatment for any reason, or death.

    Measured: 36 months after the enrollment of the last subject

  4. Overall survival (OS)

    OS is defined as the time interval from enrollment to death of any reason or censoring.

    Measured: 36 months after the enrollment of the last subject

  5. Toxicities

    Number of participants with treatment-related adverse events (TrAEs) reported between the first dose and 28 days after the last dose of study therapy as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.

    Measured: From the time of enrollment, assessed up to 28 days after the last dose of study therapy

  6. Surgical morbidity

    Surgery related adverse events (SRAEs) refer to complications which happen during or one month after surgery. Severe complications after surgery will be documented and classified by Clavien-Dindo classification, such as abdominal or GI tract bleeding, anastomotic fistula, pancreatic fistula of grade B or above, and incision complications (infection, bleeding, rupture).

    Measured: During or one month after surgery

  7. Surgical mortality

    Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.

    Measured: During or one month after surgery

Timeline

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

  1. First posted11 Dec 2024
  2. Study start1 Jul 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Why it stopped: Difficult in recruiting participants

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
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728657
Sponsor's protocol ID
FDRT-2024-251-3805
Acronym
TORCH-G
Status last verified
Jun 2025
First submitted
1 Dec 2024
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HFRT targeted to the primary lesion and positive lymph nodes, PULSAR targeted to the primary lesion and positive lymph nodes and Anti-PD-1 monoclonal antibody in people with Stomach Adenocarcinoma and Gastro-esophageal Junction Cancer, run by Fudan University 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 9 inclusion and 6 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: paused, as of the sponsor's last update on 18 Jun 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?

Results are not available in the source record.

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?

Pathological complete regression (pCR) rate (time frame: 6 months after the enrollment of the last subject). 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 NCT06728657.

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 18 Jun 2025.

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