# GAIN (AIO/CALGP/ACO)

Source: https://onco.cc/trials/gain-igbc/  
OnCo record `gain-igbc` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The German GAIN trial tried to test chemotherapy before the second operation for gallbladder cancer found by chance. It planned 333 patients but closed in October 2024 after enrolling 68, so it is unlikely to answer the question on its own.

## Summary

GAIN (NCT03673072) was a multicentre, open-label randomised phase 3 run through the German Registry of Incidental Gallbladder Carcinoma with AIO, CALGP and ACO. Patients with incidental gallbladder carcinoma after simple cholecystectomy awaiting radical liver resection, or with resectable or borderline resectable intrahepatic or extrahepatic cholangiocarcinoma, were randomised to perioperative gemcitabine and cisplatin (three cycles before and three after surgery) or surgery alone followed by investigator's choice of therapy. The primary endpoint was overall survival with progression-free survival, R0 rate, toxicity, perioperative morbidity and quality of life as secondary endpoints, and 333 patients were planned. The registry lists the trial as completed on 10 October 2024 with an actual enrolment of 68, about a fifth of the target, at a single German site entry. No results were found in Europe PMC in September 2026. Together with OPT-IN it represents the only randomised attempt to move chemotherapy ahead of re-resection in incidental gallbladder cancer.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Also known as: GAIN; GAIN-Trial
- Registry id: NCT03673072
- Phase: 3
- Setting: Incidentally detected gallbladder carcinoma after simple cholecystectomy, or resectable cholangiocarcinoma: three cycles of gemcitabine and cisplatin before and after radical liver resection versus immediate radical resection with or without adjuvant therapy
- Sponsor: Krankenhaus Nordwest
- Enrolled: 68

## Notes

- Key facts: perioperative gemcitabine and cisplatin (three cycles before and after radical resection) versus surgery first, for incidental gallbladder carcinoma after simple cholecystectomy and for resectable cholangiocarcinoma; primary endpoint overall survival; 333 planned, 68 enrolled, completed 10 October 2024 with no stated reason; no results in Europe PMC in September 2026.
- Enrolment: the registry gives 68 actual against 333 planned in the protocol paper; the trial is recorded as completed on 2024-10-10 without a stated reason.

## Sources

- ClinicalTrials.gov NCT03673072: https://clinicaltrials.gov/study/NCT03673072
- Goetze et al., BMC Cancer 2020: GAIN protocol: https://doi.org/10.1186/s12885-020-6610-4

## Connected records

- trials: [OPT-IN (EA2197)](https://onco.cc/trials/opt-in/)
- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/), [Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy](https://onco.cc/technologies/gallbladder-cancer-surgery/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/)
- institutions: [Krankenhaus Nordwest / Institute of Clinical Cancer Research (IKF)](https://onco.cc/institutions/krankenhaus-nordwest/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Radical (extended) cholecystectomy](https://onco.cc/terms/radical-cholecystectomy/)
- key papers: [Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC) - a phase III study of the German registry of incidental gallbladder carcinoma platform (GR)- the AIO/ CALGP/ ACO- GAIN-trial](https://onco.cc/key-papers/paper-gain-trial-protocol-bmc-cancer-2020/), [Neoadjuvant treatment for incidental gallbladder cancer: A systematic review](https://onco.cc/key-papers/paper-varshney-neoadjuvant-incidental-gallbladder-cancer-systematic-review-ahbps-2025/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)
- ideas: [Chemotherapy before the second operation for high-risk incidental gallbladder cancer](https://onco.cc/ideas/idea-gbc-neoadjuvant-for-high-risk-incidental-cancer/)

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